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

Study Overview
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Brief Summary
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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

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: STEM-OA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent. Joint pain ≥ 30mm on 100mm VAS at screening Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion >1 cm in any dimension by x-ray Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection) Body mass index (BMI) within the range 18 - 35 kg/m2 (both inclusive) Minimum 200 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs as judged by the investigator. Agree to donate cells to alloSTEM-OA participants. Fulfils eligibility criteria for allogeneic cell- and tissue donors. Speaks and reads Danish or English Exclusion Criteria: Active tobacco use, or use of other nicotine substitutes Active cancer or still in follow-up (5 years) Rheumatologic disease Avascular disease Severe bone deformity Previous infection of the knee joint Pes anserine bursitis pain attributed to diffuse edema pain attributed to displaced meniscal tear or osteochondritis Neurogenic or vascular claudication Bleeding disorders Chemotherapy Radiation therapy to the leg or adipose harvested site Knee injections within 3 months of treatment Unable to discontinue the following drugs 7 days before injections (prescription pain medication, anticoagulation medicine (including ibuprofen), thrombolytics, antiplatelet medication) Use of oral glucocorticoids. 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. Known chronic disease associated with metabolism malfunction or poor healing. Allergy towards necessary anaesthesia Varus/valgus malalignment >5° Isolated patellofemoral arthrosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autoSTEM-OA 400<br>400x10^6 autologous MSC(AT)s in autologous fat | Biological: STEM-OA<br>* Combination of autologous or allogeneic MSC(AT)s and fat<br>|
| Experimental: alloSTEM-OA 400<br>400x10^6 allogeneic MSC(AT)s in autologous fat | Biological: STEM-OA<br>* Combination of autologous or allogeneic MSC(AT)s and fat<br>|
| Experimental: autoSTEM-OA 800<br>800x10^6 autologous MSC(AT)s in autologous fat | Biological: STEM-OA<br>* Combination of autologous or allogeneic MSC(AT)s and fat<br>|
| Experimental: alloSTEM-OA 800<br>800x10^6 allogeneic MSC(AT)s in autologous fat | Biological: STEM-OA<br>* Combination of autologous or allogeneic MSC(AT)s and fat<br>|
| Experimental: autoSTEM-OA 1600<br>1600x10^6 autologous MSC(AT)s in autologous fat | Biological: STEM-OA<br>* Combination of autologous or allogeneic MSC(AT)s and fat<br>|
| Experimental: alloSTEM-OA 1600<br>1600x10^6 allogeneic MSC(AT)s in autologous fat | Biological: STEM-OA<br>* Combination of autologous or allogeneic MSC(AT)s and fat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STEM-OA safety | Number of treatment emergent adverse events (TEAEs) | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain | Change in KOOS 'pain' score | 13 weks | 
| Number of treatment responders | Number of treatment responders according to the OMERACT-OARSI criteria | 13 weks |