Safety and Tolerability of StroMel™ in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint

Study Overview
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Brief Summary
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The aim of this trial is to evaluate the safety and tolerability of autologous StroMel™ for the treatment of moderate to severe OA of the knee joint.

Official Title
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An Open Label Study to Evaluate Safety and Tolerability of StroMel™ in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Biological: StroMel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the ages of 25-65 years Body Mass Index (BMI) less than 40 kg/m2 Ambulatory and in good general health as described by vital signs (blood pressure 90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1 °F) and normal blood chemistry. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥ 11 (worst possible = 20) over the previous 7 days OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) within the last 6 months Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain. Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee. Have suitable knee joint anatomy for intra-articular injection. For adults of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Exclusion Criteria: Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease. Subject with an infection that requires parenteral antibiotic administration. Active infection or crystal disease in the index joint within 1 month of screening History of fracture in the index limb, joint instability, or history of acute dislocation within 12 months of screening, or fracture with sequelae at any time Intra-articular treatment of any joint with any of the following agents within 6 months of screening: Any corticosteroid preparation (investigational or marketed), sodium hyaluronate, any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection); investigational six months prior to enrollment. Presence of surgical hardware or other foreign body in the index joint Subjects who were administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks before screening. Planned or anticipated surgery of the joint during the study period Allergies to anesthesia Subjects who tested positive for HIV, HCV, WNV, CMV, HBV, HTLV, ZIKA, syphilis, flu or COVID-19. Note: CMV is not a relevant communicable disease agent. A subject who tests positive or reactive for CMV is not necessarily ineligible. Physicians will determine donor eligibility for subjects with positive CMV test results. History of lipid disorders: lipedema, lipomatosis, or lipodystrophies. Active cancer, chemotherapy, or other malignancies in the last 6 months. Recent history of DVT or pulmonary embolism requiring anticoagulants or other medicines per the hematologist. Subject who participated in another clinical trial within 3 months before the screening visit Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results. Subjects who are breastfeeding Subjects with uncontrolled arrhythmias Subjects with hemophilia; factor II, V, VII, X, or XII deficiencies; or Von Willebrand's disease.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with moderate to severe OA of the Knee<br> | Biological: StroMel<br>* Autologous MSC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of StroMel in subjects with moderate to severe OA of the kneee | Presence of adverse events in less than 10% of the study population. Adverse events assessed will be Grade 4 administrative site infection, Grade 3 hypersensitivity/anaphylaxis, >20% increase in WOMAC pain score, treatment-related disability, and presence of tumors post-treatment. | 12 months | 
| Overall Safety of StroMel | Summary of all study related AEs and SAEs. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of StroMel in managing OA of the knee | Reduction of NSAIDS, until study completion | 52 weeks | 
| Efficacy of StroMel in assessment of OA of the knee post-treatment | Percent change from baseline in rating scales (WOMAC and VAS assessments) | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell, MSC, autologous, adipose