Actively Recruiting
Study to Evaluate the Safety and Effectiveness of StromaForte Compared With Hyaluronic Acid for Knee Osteoarthritis
Led by Cellcolabs Clinical SPV Limited · Updated on 2026-04-21
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte compared to hyaluronic acid for treating knee osteoarthritis. This clinical trial is conducted by Cellcolabs Clinical SPV Limited and aims to assess pain reduction and functional improvement in adults with knee osteoarthritis. The study involves participants with Kellgren-Lawrence grade I to IV osteoarthritis and moderate to severe joint pain. Participants will receive a single dose injection of either StromaForte (mesenchymal stem cells) or hyaluronic acid as part of two treatment groups. This open-label, non-randomized study compares these two treatments directly without masking. The primary focus is on measuring pain relief at 6 months after injection, with additional follow-up assessments at 3 and 12 months to evaluate pain and functional ability. During the study, participants will undergo assessments including clinical evaluations, pain scoring using the Visual Analogue Scale, and imaging to confirm diagnosis. Researchers will monitor safety and treatment effects for up to one year post-injection. The total study duration includes enrollment, treatment, and follow-up visits to track changes in pain and joint function over time.
CONDITIONS
Brief 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 63 18 years 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 grade I to IV on the Kellgren-Lawrence scale.
- Joint pain during activity assessed by Visual Analogue Scale of 63 40 at screening.
- Body Mass Index between 63 18.5 and 5c 35.0 kg/m2.
You will not qualify if you...
- Unwilling or unable to perform assessments required by the protocol.
- Mechanically unstable knee due to complete ligament tears.
- Varus or valgus 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 of infectious or inflammatory joint disorders.
- Systemic or intra-articular corticosteroid injection within 3 months before screening.
- Immunosuppression due to illness or medication including high dose corticosteroids.
- Planned orthopedic surgery on lower limbs within 12 months.
- Active or suspected infection.
- History of malignancy in past 2.5 years except treated in-situ cancers.
- Severe bleeding disorders.
- Participation in another clinical trial with investigational product within 30 days.
- Pregnancy or breastfeeding.
- Unable or not recommended to pause anticoagulant medications.
- Known diagnosis of certain infectious diseases including HIV, Hepatitis, or Syphilis.
- Recent serious embolic disease within 4 months.
- Allergies to DMSO, human serum albumin, heparin, or PlasmaLyte.
- Conditions or therapies that might confound study results or interfere with participation.
- Cognitive or language barriers preventing consent or study participation.
- Received any stem cell therapy within previous 12 months.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with follow-up to 1 year
Participants receive a single dose injection of either StromaForte (mesenchymal stem cells) or hyaluronic acid for knee osteoarthritis.
1 treatment visit and multiple follow-up visits over 12 months
Duration - Up to 12 months
Participants are monitored for safety and effectiveness outcomes including pain reduction and functional improvement up to 12 months after treatment.
Follow-up visits at 3, 6, and 12 months post-injection
Trial Site Locations
Total: 1 location
1
Burjeel Medical City
Abu Dhabi, United Arab Emirates
Actively Recruiting
Research Team
B
Bahar Kasaei
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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