NCT07542808 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
| NCT ID | NCT07542808 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Cellcolabs Clinical SPV Limited |
| Condition | Knee Arthritis Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-09-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2026-04-27 with a primary completion date of 2027-09-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
StromaForte injection for knee OA
Eligibility Criteria
Inclusion Criteria: * 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 osteoarthritis (OA) based on the criteria established by the American College of Rheumatology, confirmed through radiological images no older than three months. * Grade I to IV osteoarthritis on the Kellgren-Lawrence radiological classification scale. * Joint pain during activity as assessed by the Visual Analogue Scale (VAS) of ≥ 40 at the time of screening * Body Mass Index (BMI) between ≥ 18.5 to ≤ 35.0 kg/m2 Exclusion Criteria: * Unwilling or unable to perform any of the assessments required by the protocol. * Mechanically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear. * Varus or valgus malalignment \>5 degrees as measured by 4-foot standing antero-posterior radiographs. * History of subtotal medial or lateral meniscectomy performed less than 9 months ago. * History of septic arthritis in the targeted knee. * History of infectious or inflammatory joint disorders or suspected infective or inflammatory joint disease. * Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening. * Immunosuppression due to illness or medication including but not limited to high dose corticosteroids, calcineurin inhibitors, anti-TNF, anti-IL-6, anti-p40, biologics and prednisone and/or equivalent over 5 mg/day. * Planned orthopaedic surgery on lower limbs within the next 12 months * Active or suspected infection. * History of malignancy in the past 2.5 years, except in-situ cancers treated by local excision with curative intent. * Severe bleeding diathesis. * Participation in another clinical trial including treatment with a different investigational product within 30 days prior to inclusion in this study. * Pregnancy or breastfeeding. * Unwilling or for medical reason not recommended to pause anticoagulant medications prior to procedure, as judged by prescribing doctor. * Known diagnosis of HIV-1, HIV-2, Hepatitis A, Hepatitis B, Hepatitis C, HTLV-I/II, or Syphilis, or other acute or chronic infectious disease. * Pulmonary embolism, deep vein thrombosis or other serious embolic disease within the past 4 months. * Known allergies or hypersensitivity to DMSO, human serum albumin, heparin or PlasmaLyte. * History or current evidence of any condition, therapy, laboratory abn ormality, or other circumstance that might confound the results of the study or interfere with the study participant's participation for the full duration of the study. * Cognitive or language barriers that prohibit obtaining informed consent, questionnaires or any study elements. * Recipient of any stem cell therapy within the previous 12 months
Contact & Investigator
Ola Jeppsson
STUDY DIRECTOR
Cellcolabs Clinical SPV Limited
Frequently Asked Questions
Who can join the NCT07542808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Arthritis Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07542808 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07542808 currently recruiting?
Yes, NCT07542808 is actively recruiting participants. Contact the research team at hello@cellcolabs.com for enrollment information.
Where is the NCT07542808 trial being conducted?
This trial is being conducted at Abu Dhabi, United Arab Emirates.
Who is sponsoring the NCT07542808 clinical trial?
NCT07542808 is sponsored by Cellcolabs Clinical SPV Limited. The principal investigator is Ola Jeppsson at Cellcolabs Clinical SPV Limited. The trial plans to enroll 140 participants.