Evaluating StromaForte for treating knee osteoarthritis

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

This study is testing if an injection of StromaForte can be safe and well-tolerated for adults with mild-to-moderate knee osteoarthritis.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cellcolabs Clinical SPV Limited (Industry-sponsored)
• Locations: 1 site (Abu Dhabi)
• Trial ID: NCT06084988 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm phase I/II study aims to assess the safety and tolerability of StromaForte, a human allogeneic bone marrow-derived mesenchymal stromal cell product, in patients with mild-to-moderate knee osteoarthritis. A total of 12 participants aged over 18 will receive a single intra-articular injection of StromaForte, and their safety will be monitored through various follow-up assessments over a period of 168 days. The study will track adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) to evaluate the treatment's safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with mild to moderate knee osteoarthritis who have not responded to conservative management.

Not a fit: Patients with severe knee osteoarthritis or those who have had recent knee surgeries may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a novel approach to managing knee osteoarthritis by potentially reducing inflammation and promoting joint health.

How similar studies have performed: While the use of mesenchymal stromal cells is an emerging field, this specific application for knee osteoarthritis is still being explored and has not been widely tested in prior studies.

Eligibility criteria

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

Where this trial is running

Abu Dhabi

• Burjeel Medical City — Abu Dhabi, United Arab Emirates (Recruiting)

Study contacts

• Principal investigator: Fahti Yousef, PhD — Cellcolabs Clinical SPV Limited
• Study coordinator: Nadir Kadri

Conditions Osteo Arthritis Knee