Actively Recruiting
An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis
Led by Cellcolabs Clinical SPV Limited · Updated on 2026-04-21
140
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
StromaForte injection for knee OA
CONDITIONS
Official Title
An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- Aged 18 years or older at the time of signing the informed consent form.
- Diagnosed with knee osteoarthritis based on American College of Rheumatology criteria, confirmed by radiological images no older than three months.
- Osteoarthritis severity grade I to IV according to the Kellgren-Lawrence radiological classification scale.
- Joint pain during activity with a score of 40 or higher on the Visual Analogue Scale (VAS) at screening.
- Body Mass Index (BMI) between 18.5 and 35.0 kg/m2
You will not qualify if you...
- Unwilling or unable to perform any assessments required by the protocol.
- Mechanically unstable knee due to complete ligament tears (anterior cruciate, posterior cruciate, medial collateral, or posterolateral corner).
- Varus or valgus knee malalignment greater than 5 degrees.
- History of subtotal medial or lateral meniscectomy less than 9 months ago.
- History of septic arthritis in the targeted knee.
- History or suspicion of infectious or inflammatory joint disorders.
- Systemic or intra-articular corticosteroid injections in any joint within 3 months before screening.
- Immunosuppression due to illness or medications like high dose corticosteroids, calcineurin inhibitors, anti-TNF, anti-IL-6, anti-p40, biologics, prednisone over 5 mg/day.
- Planned orthopedic surgery on lower limbs within the next 12 months.
- Active or suspected infection.
- History of malignancy in the past 2.5 years except for in-situ cancers treated by local excision.
- Severe bleeding disorders.
- Participation in another clinical trial with different investigational products within 30 days prior to inclusion.
- Pregnancy or breastfeeding.
- Unwilling or medically not recommended to pause anticoagulant medications prior to procedure.
- Known infections such as HIV-1, HIV-2, Hepatitis A, B, or C, HTLV-I/II, Syphilis, or other acute or chronic infectious diseases.
- Pulmonary embolism, deep vein thrombosis, or serious embolic disease within the past 4 months.
- Known allergies or hypersensitivity to DMSO, human serum albumin, heparin, or PlasmaLyte.
- Any condition, therapy, abnormal lab results, or circumstance that might interfere with study participation or results.
- Cognitive or language barriers preventing informed consent or study participation.
- Receipt of any stem cell therapy within the previous 12 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Burjeel Medical City
Abu Dhabi, United Arab Emirates
Actively Recruiting
Research Team
B
Bahar Kasaei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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