CClinicalTrials.gg
Status unknownNCT05789719Updated Mar 29, 2023

An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis

A Phase 1 interventional study of STEM-OA in Osteoarthritis, Knee, sponsored by StemMedical A/S. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by StemMedical A/S · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with StemMedical A/S as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  2. Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent.
  3. Joint pain ≥ 30mm on 100mm VAS at screening
  4. Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion >1 cm in any dimension by x-ray
  5. Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection)
  6. Body mass index (BMI) within the range 18 - 35 kg/m2 (both inclusive)
  7. Minimum 200 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs as judged by the investigator.
  8. Agree to donate cells to alloSTEM-OA participants.
  9. Fulfils eligibility criteria for allogeneic cell- and tissue donors.
  10. Speaks and reads Danish or English

Exclusion criteria

Exclusion Criteria:

  1. Active tobacco use, or use of other nicotine substitutes
  2. Active cancer or still in follow-up (5 years)
  3. Rheumatologic disease
  4. Avascular disease
  5. Severe bone deformity
  6. Previous infection of the knee joint
  7. Pes anserine bursitis
  8. pain attributed to diffuse edema
  9. pain attributed to displaced meniscal tear or osteochondritis
  10. Neurogenic or vascular claudication
  11. Bleeding disorders
  12. Chemotherapy
  13. Radiation therapy to the leg or adipose harvested site
  14. Knee injections within 3 months of treatment
  15. Unable to discontinue the following drugs 7 days before injections (prescription pain medication, anticoagulation medicine (including ibuprofen), thrombolytics, antiplatelet medication)
  16. Use of oral glucocorticoids.
  17. Female who is pregnant, breast-feeding or intends to become pregnant within 1-year after the treatment, or is of child-bearing potential and not using highly effective contraceptive method.
  18. Known chronic disease associated with metabolism malfunction or poor healing.
  19. Allergy towards necessary anaesthesia
  20. Varus/valgus malalignment >5°
  21. Isolated patellofemoral arthrosis
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    autoSTEM-OA 400

    400x10\^6 autologous MSC(AT)s in autologous fat

    Biological: STEM-OA

  • Experimental
    alloSTEM-OA 400

    400x10\^6 allogeneic MSC(AT)s in autologous fat

    Biological: STEM-OA

  • Experimental
    autoSTEM-OA 800

    800x10\^6 autologous MSC(AT)s in autologous fat

    Biological: STEM-OA

  • Experimental
    alloSTEM-OA 800

    800x10\^6 allogeneic MSC(AT)s in autologous fat

    Biological: STEM-OA

  • Experimental
    autoSTEM-OA 1600

    1600x10\^6 autologous MSC(AT)s in autologous fat

    Biological: STEM-OA

  • Experimental
    alloSTEM-OA 1600

    1600x10\^6 allogeneic MSC(AT)s in autologous fat

    Biological: STEM-OA

Interventions

  • BiologicalSTEM-OA

    Combination of autologous or allogeneic MSC(AT)s and fat

06

What researchers measure

Primary outcomes

  1. STEM-OA safety

    Number of treatment emergent adverse events (TEAEs)

    Time frame: 13 weeks

Secondary outcomes

  1. Knee pain

    Change in KOOS 'pain' score

    Time frame: 13 weks

  2. Number of treatment responders

    Number of treatment responders according to the OMERACT-OARSI criteria

    Time frame: 13 weks

07

Study locations

1 site
  • Sanos Clinic Syddanmark
    Vejle, 7100, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05789719
Lead sponsor
StemMedical A/S
Responsible party
Sponsor
First posted
Mar 29, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 1, 2024 (estimated)
Last update
Mar 29, 2023

Study contacts

Jesper Due Jensen, PhD
Contact
jj@stemmedical.com
+45 51222087

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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