A Phase 2 interventional study of Autologous Stomal Vascular Fraction Material and Ringer's solution in Rotator Cuff Tear, Muscle Atrophy and Tendon Tear, sponsored by Hospital for Special Surgery, New York. Active, not recruiting at 1 site in United States. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Hospital for Special Surgery, New York · Phase 2, Interventional, and Treatment
Among 168 studies in Rotator Cuff Injuries with a site in United States — 40 open to participants now, 50 under way, none of them phase 3. Rotator Cuff Injuries · United States.
Among the 168 studies in Rotator Cuff Injuries with a site in United States, this one is the 69th largest by planned enrollment of the 130 interventional ones that give a count, is one of 20 that started in 2019, is one of 6 in phase 2, reaches primary completion later than 14 of the 49 other live ones, and was the 52nd registered.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
Browse Rotator Cuff Injuries studies →40 of the 168 studies in Rotator Cuff Injuries with a site in United States are open now. Recruiting first, the newest first:
Joseph W. Galvin · Sites in United States
Tego Science, Inc. · Sites in United States
The Cleveland Clinic · Sites in United States
ZuriMED Technologies Inc. · Sites in United States
University Hospitals Cleveland Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 100 Rotator Cuff Injuries studies recruiting now, 40 (40%) set no upper age limit and 41 (41%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 45 Years to 65 Years · all sexes · no healthy volunteers.
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168 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 11 · Phase 3 5 · Phase 4 22
First in 2005; this study’s year is marked. 20 started in 2019.
This study's planned enrollment of 56 is close to the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Median enrollment 60 across the 130 interventional studies, 77 across the 38 observational. Of the 86 that completed or were terminated, 28 (33%) have results posted.
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40 of 168 have an industry lead sponsor. The 10 most frequent:
Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
Hospital for Special Surgery, New York has 2 studies filed under Rotator Cuff Injuries — fewer than ten, so there is no comparison to draw.
29 of the studies in Rotator Cuff Injuries with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06735170University of MinnesotaTuberoplasty Versus Balloon Spacer | 2026-11-26 |
| NCT07851233Rothman Institute OrthopaedicsPatient Education and Sling Use After Shoulder Surgery | 2026-11-30 |
| NCT06039345University of UtahShoulder RFA Pilot Study | 2026-12 |
| NCT05011331Rhode Island HospitalThe Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome | 2026-12 |
| NCT06669741Texas Bone and JointClinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear | 2026-12-01 |
Among the 168 studies in Rotator Cuff Injuries with a site in United States, from their registry updates:
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Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair
Device: Ringer's solution
Patients will receive an injection of stromal vascular fraction material suspended in vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair
Device: Autologous Stomal Vascular Fraction Material
Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™
Ringer's solution
Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function.
Time frame: 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
Change in Penn Shoulder score, ASES score and Short Form Global Health scale (PROMIS-SF) from baseline (range 0 minimum to 30 maximum)
Time frame: 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
Change in supraspinatus muscle stiffness from baseline, measured by ultrasound shear wave elastrography
Time frame: 1 month prior to surgery, 6 months after surgery, 24 months after surgery
Change in fatty infiltration from baseline, measured by magnetic resonance imaging
Time frame: 1 month prior to surgery, 6 months after surgery, 24 months after surgery
Started Jul 2019 (actual). Primary completion is estimated for Dec 2026, 89 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital for Special Surgery, New York →