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

• Sponsor: StemMedical A/S (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05789719
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Biological: STEM-OA	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: autoSTEM-OA 400 400x10^6 autologous MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: alloSTEM-OA 400 400x10^6 allogeneic MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: autoSTEM-OA 800 800x10^6 autologous MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: alloSTEM-OA 800 800x10^6 allogeneic MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: autoSTEM-OA 1600 1600x10^6 autologous MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat
Experimental: alloSTEM-OA 1600 1600x10^6 allogeneic MSC(AT)s in autologous fat	Biological: STEM-OA; Combination of autologous or allogeneic MSC(AT)s and fat

Outcome Measures

Primary Outcome Measures

1. STEM-OA safety [13 weeks]

   Number of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

1. Knee pain [13 weks]

   Change in KOOS 'pain' score

2. Number of treatment responders [13 weks]

   Number of treatment responders according to the OMERACT-OARSI criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanos Clinic Syddanmark	Vejle		Denmark	7100

Sponsors and Collaborators

• StemMedical A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: StemMedical A/S
• ClinicalTrials.gov Identifier: NCT05789719
• Other Study ID Numbers: ST-001
• First Posted: Mar 29, 2023
• Last Update Posted: Mar 29, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Mar 29, 2023