An Open-Label Single-Arm Phase I/IIa Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte for the Treatment of Knee Osteoarthritis

00-OA Study-2022

This open-label, single-arm, phase I/II study in mild-to-moderate stage knee osteoarthritis patients is designed to assess the safety and tolerability of intraarticular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. 12 male and/or female patients aged over 18 years will be enrolled. The main questions it aims to answer are: To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs). Eligible patients will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasoundguided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte

2023-11-08

2024-11-08

2025-04-07

Recruiting

Early phase I

12

Inclusion Criteria: 1. Willing and able to provide written informed consent and comply with all procedures required by the protocol 2. Aged \> 18 years at the time of signing the informed consent form 3. Diagnosed with knee OA according to American College and Rheumatology criteria and showing a stage of a mild to moderate arthritis. 4. Kellgren-Lawrence radiological classification scale II and III at screening 5. Visual analogue scale (VAS) joint pain ≥ 2.5 at screening 6. Have tried but failed conservative management including physical therapy, bracing and medications for a minimum of three months. 7. No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months 8. No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year 9. Adequate liver and renal functions with non-malignant blood profile. 10. Body Mass Index between 20 and 30 kg/m2 11. Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing 12. Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection. 13. Fluid \> 1 cm within the lateral recess of the suprapatellar pouch at the level of the superior pole of the patella with the knee extended. Exclusion Criteria: 1. Unwilling or unable to perform any of the assessments required by the protocol 2. Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear 3. Patients with varus or valgus malalignment \>5 degrees as measured by 4-foot standing antero-posterior radiographs 4. Patients with a history of a previous subtotal medial or lateral meniscectomy 5. Patients with a history of septic arthritis in the affected joint 6. Patients with a history of a prior intra-articular knee fracture 7. Severe bleeding diathesis 8. Active infection 9. Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g., patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator 10. Patients with neoplasia 11. Patients participating in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in this study 12. Patients with a known history of inflammatory or rheumatic diseases such as rheumatoid arthritis

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2023-11-22