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

Phase 1

Not yet recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: STEM-OA

• Registration Number: NCT05789719
• Lead Sponsor: StemMedical A/S

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29
• Study Start: 2023-11-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alloSTEM-OA 1600	STEM-OA	1600x10\^6 allogeneic MSC(AT)s in autologous fat
autoSTEM-OA 400	STEM-OA	400x10\^6 autologous MSC(AT)s in autologous fat
alloSTEM-OA 800	STEM-OA	800x10\^6 allogeneic MSC(AT)s in autologous fat
alloSTEM-OA 400	STEM-OA	400x10\^6 allogeneic MSC(AT)s in autologous fat
autoSTEM-OA 800	STEM-OA	800x10\^6 autologous MSC(AT)s in autologous fat
autoSTEM-OA 1600	STEM-OA	1600x10\^6 autologous MSC(AT)s in autologous fat

Primary Outcome Measures

Name	Time	Method
STEM-OA safety	13 weeks	Number of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Knee pain	13 weks	Change in KOOS 'pain' score
Number of treatment responders	13 weks	Number of treatment responders according to the OMERACT-OARSI criteria

Trial Locations

Locations (1)

Sanos Clinic Syddanmark; 🇩🇰 Vejle, Denmark