Investigating the Safety and Regenerative Potential of MSC-Derived Secretome Combined With PRGF i… (NCT07157891) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Investigating the Safety and Regenerative Potential of MSC-Derived Secretome Combined With PRGF in Knee Osteoarthritis
25 participantsStarted 2025-12-10
Plain-language summary
This Phase I/II randomized clinical trial investigates the safety, feasibility, and early regenerative potential of intra-articular administration of mesenchymal stem cell (MSC)-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with knee osteoarthritis (KOA). The study aims to assess whether this cell-free, biologically enriched therapeutic combination can reduce pain, improve joint function, and promote cartilage repair.
Who can participate
Age range
30 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Following is the inclusion criteria for the enrolment of patients affected with damaged cartilage in this study:
* Diagnosed with primary OA in one or both knees based on American College of Rheumatology criteria
* Grade I and II Arthritis
* Joint pain ≥ 20mm measured by visual analogue scale
* Age ranges from 30-55 years of age
* BMI 27.12 ± 4.38
* Patients with no previous surgical interventions to lower limb
* Willing to participate in the study
Exclusion Criteria:
* • Secondary OA due to trauma, infection, rheumatoid arthritis, congenital disease or other inflammatory disorders of the knee
* Diagnosed with a systemic autoimmune disorder, immunodeficiency or coagulation disorder
* Had history of malignancy
* History of allergy or allergic constitution
* Pregnant or breastfeeding women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Knee Pain (VAS Score) Change in WOMAC Score Adverse Events (Safety Monitoring)
Timeframe: From enrollment through the treatment period (Day 0 to Day 14); and at follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment.