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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05789719
• Other study ID #: ST-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2023
• Source: StemMedical A/S
• Contact: Jesper Due Jensen, PhD
• Phone: +45 51222087
• Email: jj[@]stemmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• STEM-OA
Combination of autologous or allogeneic MSC(AT)s and fat

Locations

Country	Name	City	State
Denmark	Sanos Clinic Syddanmark	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
StemMedical A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STEM-OA safety	Number of treatment emergent adverse events (TEAEs)	13 weeks
Secondary	Knee pain	Change in KOOS 'pain' score	13 weks
Secondary	Number of treatment responders	Number of treatment responders according to the OMERACT-OARSI criteria	13 weks