Status:
UNKNOWN
A Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte for the Treatment of Knee Osteoarthritis
Lead Sponsor:
Cellcolabs Clinical SPV Limited
Collaborating Sponsors:
PDC-CRO
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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-de...
Detailed Description
Osteoarthritis (OA) is a severe, chronic, and progressive disease that eventually leads to disability. OA is characterized by joint pain, stiffness, limited mobility with effusion, and inflammation. I...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent and comply with all procedures required by the protocol
- Aged \> 18 years at the time of signing the informed consent form
- Diagnosed with knee OA according to American College and Rheumatology criteria and showing a stage of a mild to moderate arthritis.
- Kellgren-Lawrence radiological classification scale II and III at screening
- Visual analogue scale (VAS) joint pain ≥ 2.5 at screening
- Have tried but failed conservative management including physical therapy, bracing and medications for a minimum of three months.
- No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
- No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
- Adequate liver and renal functions with non-malignant blood profile.
- Body Mass Index between 20 and 30 kg/m2
- Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
- 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.
- 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
- Unwilling or unable to perform any of the assessments required by the protocol
- 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
- Patients with varus or valgus malalignment \>5 degrees as measured by 4-foot standing antero-posterior radiographs
- Patients with a history of a previous subtotal medial or lateral meniscectomy
- Patients with a history of septic arthritis in the affected joint
- Patients with a history of a prior intra-articular knee fracture
- Severe bleeding diathesis
- Active infection
- 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
- Patients with neoplasia
- Patients participating in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in this study
- Patients with a known history of inflammatory or rheumatic diseases such as rheumatoid arthritis
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 7 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06084988
Start Date
November 8 2023
End Date
April 7 2025
Last Update
November 22 2023
Active Locations (1)
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1
Burjeel Medical City
Abu Dhabi, United Arab Emirates