Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

Browse trials for

• Tendinopathy 397
• Tennis Elbow 296

Keywords

• Micro-fragmented adipose tissue
• autologous fat grafting
• adipose-derived stem cells
• regenerative medicine
• orthobiologics
• percutaneous tenotomy,
• ultrasound-guided injection
• chronic tendinopathy
• tendinopathy
• lateral epicondylitis
• rotator cuff tendinopathy
• Achilles tendinopathy
• ASSET
• Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy

Tendinopathy

397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.

This study's planned enrollment of 40 is below the median of 48 across 332 interventional studies indexed under Tendinopathy.

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Study arms

• Experimental
  Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) Injection

  All participants receive a single, one-time autologous fat grafting procedure (no comparison group). A small volume of abdominal fat (5-15 cc) is harvested by manual liposuction under local anesthesia and concentrated by gentle manual rolling on non-adherent (Telfa) dressings to create concentrated autologous lipoaspirate, known as the Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) therapy. Under ultrasound guidance, the target tendon undergoes percutaneous tenotomy (needle fenestration) to disrupt scar tissue, followed by intratendinous injection of 1-3 cc of concentrated ASSET. Participants are then followed for 12 months with patient-reported pain and function questionnaires and ultrasound imaging. This is a single-arm, open-label study in which each participant serves as their own baseline control.

  Procedure: Adipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) Injection

Interventions

• ProcedureAdipose Stem/Stromal Cells for Enthesis/Tendon Therapy (ASSET) Injection

  ASSET i.e., mechanically concentrated autologous lipoaspirate, prepared and delivered in a single, same-day, point-of-care procedure. Under local anesthesia, 5-15 cc of subcutaneous abdominal fat is harvested by small-volume manual liposuction. The lipoaspirate is sterilely rinsed and concentrated by manual rolling on a non-adherent (Telfa) dressing; no enzymatic (collagenase) digestion, cell isolation, culture, or expansion is performed (minimal manipulation). Under ultrasound guidance, percutaneous tenotomy (needle fenestration) of the target tendon is performed, followed by a single intratendinous injection of 1-3 cc of the concentrated graft into the area of tendinopathy. One-time administration; route is percutaneous intratendinous injection. No exogenous cells, additives, scaffolds, or culture are used; the graft is autologous and delivered within the same surgical procedure.

Primary outcomes

1. Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months

   Pain in the affected tendon is self-reported on the 11-point Numeric Rating Scale (NRS), an integer from 0 to 10 where 0 = no pain and 10 = worst pain imaginable. The outcome is the mean change from baseline (pre-procedure) to Month 6, calculated as the Month 6 score minus the baseline score. A negative change indicates improvement; a lower score is a better outcome.

   Time frame: Baseline (pre-procedure) and Month 6

Secondary outcomes

1. Change From Baseline in Patient-Reported Pain (NRS) at Week 6

   Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Week 6. (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.

   Time frame: Baseline, Week 6

2. Change From Baseline in Patient-Reported Pain (NRS) at Month 3

   Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 3 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.

   Time frame: Baseline, Month 3

3. Change From Baseline in Patient-Reported Pain (NRS) at Month 12

   Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 12 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome.

   Time frame: Baseline, Month 12

4. Mean Change From Baseline in LEFS at Week 6

   The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

   Time frame: Baseline - Week 6

5. Mean Change From Baseline in LEFS at Month 3

   The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

   Time frame: Baseline - Month 3

6. Mean Change From Baseline in LEFS at Month 6

   The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

   Time frame: Baseline - Month 6

7. Mean Change From Baseline in LEFS at Month 12

   The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

   Time frame: Baseline - Month 12

8. Mean Change From Baseline in HOOS Pain Subscale at Week 6

   The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

   Time frame: Baseline - Week 6

9. Mean Change From Baseline in HOOS Pain Subscale at Month 3

   The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

   Time frame: Baseline - Month 3

10. Mean Change From Baseline in HOOS Pain Subscale at Month 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

    Time frame: Baseline - Month 6

11. Mean Change From Baseline in HOOS Pain Subscale at Month 12

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

    Time frame: Baseline - Month 12

12. Mean Change From Baseline in HOOS Symptoms Subscale at Week 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

    Time frame: Baseline - Week 6

13. Mean Change From Baseline in HOOS Symptoms Subscale at Month 3

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

    Time frame: Baseline - Month 3

14. Mean Change From Baseline in HOOS Symptoms Subscale at Month 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

    Time frame: Baseline - Month 6

15. Mean Change From Baseline in HOOS Symptoms Subscale at Month 12

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

    Time frame: Baseline - Month 12

16. Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Week 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

    Time frame: Baseline - Week 6

17. Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 3

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

    Time frame: Baseline - Month 3

18. Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

    Time frame: Baseline - Month 6

19. Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 12

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

    Time frame: Baseline - Month 12

20. Mean Change From Baseline in HOOS Sport/Recreation Subscale at Week 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

    Time frame: Baseline - Week 6

21. Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 3

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

    Time frame: Baseline - Month 3

22. Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

    Time frame: Baseline - Month 6

23. Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 12

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

    Time frame: Baseline - Month 12

24. Mean Change From Baseline in HOOS Quality of Life Subscale at Week 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

    Time frame: Baseline - Week 6

25. Mean Change From Baseline in HOOS Quality of Life Subscale at Month 3

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

    Time frame: Baseline - Month 3

26. Mean Change From Baseline in HOOS Quality of Life Subscale at Month 6

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

    Time frame: Baseline - Month 6

27. Mean Change From Baseline in HOOS Quality of Life Subscale at Month 12

    The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

    Time frame: Baseline - Month 12

28. Mean Change From Baseline in DASH at Week 6

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a negative change indicates improvement.

    Time frame: Baseline - Week 6

29. Mean Change From Baseline in DASH at Month 3

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a negative change indicates improvement.

    Time frame: Baseline - Month 3

30. Mean Change From Baseline in DASH at Month 6

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a negative change indicates improvement.

    Time frame: Baseline - Month 6

31. Mean Change From Baseline in DASH at Month 12

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a negative change indicates improvement.

    Time frame: Baseline - Month 12

32. Mean Change From Baseline in MEPI at Week 6

    The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

    Time frame: Baseline - Week 6

33. Mean Change From Baseline in MEPI at Month 3

    The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

    Time frame: Baseline - Month 3

34. Mean Change From Baseline in MEPI at Month 6

    The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

    Time frame: Baseline - Month 6

35. Mean Change From Baseline in MEPI at Month 12

    The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

    Time frame: Baseline - Month 12

36. Mean Change From Baseline in VISA-A at Week 6

    The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement.

    Time frame: Baseline - Week 6

37. Mean Change From Baseline in VISA-A at Month 3

    The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement.

    Time frame: Baseline - Month 3

38. Mean Change From Baseline in VISA-A at Month 6

    The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement.

    Time frame: Baseline - Month 6

39. Mean Change From Baseline in VISA-A at Month 12

    The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement.

    Time frame: Baseline - Month 12

40. Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Week 6

    Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Week 6; a negative change (reduction in thickness toward normal) indicates improvement.

    Time frame: Baseline - Week 6

41. Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 3

    Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 3; a negative change (reduction in thickness toward normal) indicates improvement.

    Time frame: Baseline - Month 3

42. Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 6

    Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 6; a negative change (reduction in thickness toward normal) indicates improvement.

    Time frame: Baseline - Month 6

43. Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 12

    Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 12; a negative change (reduction in thickness toward normal) indicates improvement.

    Time frame: Baseline - Month 12

44. Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Week 6

    Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Week 6; a negative change (a lower score, indicating more normal architecture) indicates improvement.

    Time frame: Baseline - Week 6

45. Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 3

    Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 3; a negative change (a lower score, indicating more normal architecture) indicates improvement.

    Time frame: Baseline - Month 3

46. Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 6

    Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 6; a negative change (a lower score, indicating more normal architecture) indicates improvement.

    Time frame: Baseline - Month 6

47. Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 12

    Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 12; a negative change (a lower score, indicating more normal architecture) indicates improvement.

    Time frame: Baseline - Month 12

48. Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Week 6

    Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Week 6; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Week 6

49. Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 3

    Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 3; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Month 3

50. Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 6

    Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 6; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Month 6

51. Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 12

    Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 12; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Month 12

52. Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Week 6

    Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Week 6; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Week 6

53. Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 3

    Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 3; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Month 3

54. Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 6

    Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 6; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Month 6

55. Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 12

    Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 12; a negative change (a lower score) indicates improvement.

    Time frame: Baseline - Month 12

56. Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Week 6

    The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Week 6, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.

    Time frame: Week 6

57. Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 3

    The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 3, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.

    Time frame: Month 3

58. Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 6

    The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 6, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.

    Time frame: Month 6

59. Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 12

    The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 12, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization.

    Time frame: Month 12

60. Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Week 6

    The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Week 6, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.

    Time frame: Week 6

61. Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 3

    The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 3, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.

    Time frame: Month 3

62. Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 6

    The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 6, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.

    Time frame: Month 6

63. Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 12

    The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 12, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence.

    Time frame: Month 12

64. Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Week 6

    Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Week 6; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.

    Time frame: Baseline - Week 6

65. Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 3

    Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 3; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.

    Time frame: Baseline - Month 3

66. Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 6

    Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 6; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.

    Time frame: Baseline - Month 6

67. Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 12

    Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 12; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan.

    Time frame: Baseline - Month 12

68. Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Week 6

    Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.

    Time frame: Week 6

69. Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 3

    Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.

    Time frame: Month 3

70. Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 6

    Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.

    Time frame: Month 6

71. Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 12

    Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment.

    Time frame: Month 12

72. Number and Severity of Adverse Events (Safety and Tolerability)

    Safety is assessed as the number of participants with adverse events (AEs), with AEs tabulated by type, severity (e.g., mild/moderate/severe), seriousness, and attribution/relatedness to the procedure. Harvest (liposuction)-site and injection-site events are captured.

    Time frame: From procedure (Day 0) through Month 12

Publications

• Fick B, Stover DW, Chimenti RL, Hall MM. The Safety of Ultrasound Guided Tenotomy and Debridement for Upper and Lower Extremity Tendinopathies: A Retrospective Study. Iowa Orthop J. 2021 Dec;41(2):82-90. PubMed 34924874 ↗
• Aljerian A, Abi-Rafeh J, Hemmerling T, Gilardino MS. Complications of Aesthetic Liposuction Performed in Isolation: A Systematic Literature Review and Meta-Analysis. Plast Surg (Oakv). 2024 Feb;32(1):19-32. doi: 10.1177/22925503221078693. Epub 2022 Feb 21. PubMed 38433796 ↗
• Jo CH, Chai JW, Jeong EC, Oh S, Kim PS, Yoon JY, Yoon KS. Intratendinous Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A First-In-Human Trial. Stem Cells. 2018 Sep;36(9):1441-1450. doi: 10.1002/stem.2855. Epub 2018 Jul 16. PubMed 29790618 ↗
• Strong AL, Rubin JP, Kozlow JH, Cederna PS. Fat Grafting for the Treatment of Scleroderma. Plast Reconstr Surg. 2019 Dec;144(6):1498-1507. doi: 10.1097/PRS.0000000000006291. PubMed 31764674 ↗
• Palumbo Piccionello A, Riccio V, Senesi L, Volta A, Pennasilico L, Botto R, Rossi G, Tambella AM, Galosi L, Marini C, Vullo C, Gigante A, Zavan B, De Francesco F, Riccio M. Adipose micro-grafts enhance tendinopathy healing in ovine model: An in vivo experimental perspective study. Stem Cells Transl Med. 2021 Nov;10(11):1544-1560. doi: 10.1002/sctm.20-0496. Epub 2021 Aug 16. PubMed 34398527 ↗
• Oshita T, Tobita M, Tajima S, Mizuno H. Adipose-Derived Stem Cells Improve Collagenase-Induced Tendinopathy in a Rat Model. Am J Sports Med. 2016 Aug;44(8):1983-9. doi: 10.1177/0363546516640750. Epub 2016 Apr 11. PubMed 27159294 ↗
• Nourissat G, Berenbaum F, Duprez D. Tendon injury: from biology to tendon repair. Nat Rev Rheumatol. 2015 Apr;11(4):223-33. doi: 10.1038/nrrheum.2015.26. Epub 2015 Mar 3. PubMed 25734975 ↗
• Hopkins C, Fu SC, Chua E, Hu X, Rolf C, Mattila VM, Qin L, Yung PS, Chan KM. Critical review on the socio-economic impact of tendinopathy. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2016 Apr 22;4:9-20. doi: 10.1016/j.asmart.2016.01.002. eCollection 2016 Apr. PubMed 29264258 ↗
• Kaux JF, Forthomme B, Goff CL, Crielaard JM, Croisier JL. Current opinions on tendinopathy. J Sports Sci Med. 2011 Jun 1;10(2):238-53. PubMed 24149868 ↗

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared in a public repository. This is a single-site pilot study with a small planned enrollment (N=40) spanning multiple, sometimes uncommon, tendinopathy sites; even after de-identification, the limited sample size and granular clinical, imaging, and correlative flow-cytometry data create a residual risk of participant re-identification. Summary (aggregate) results will be posted to ClinicalTrials.gov and disseminated through peer-reviewed publication and scientific presentation. Reasonable requests for de-identified data from qualified academic investigators may be considered by the Principal Investigator on a case-by-case basis, subject to Weill Cornell Medicine IRB approval and a signed data-use agreement that protects participant confidentiality.