Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs) (NCT06103396) | Clinical Trial Compass
UnknownPhase 1/2
Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)
Venezuela30 participantsStarted 2018-01-30
Plain-language summary
The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.
Who can participate
Age range
10 Years – 85 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:
* Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment
* Patients with or without previous orthopaedic treatment
* Presence of nonunion 9 month or more
* Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length
Exclusion Criteria:
* Evidence of infection at the nonunion site (Osteomielitis)
* Evidence of cutaneous lesion at the site of pseudoartrosis
* Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections
* Autoimmune diseases
* Neoplastic diseases
* Pregnancy
* Major metabolic disorders
* Treatment with steroids
* Other conditions or circumstances that compromise the study participation according to medical criteria
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
Clinical evaluation
Timeframe: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
2
Bone consolidation
Timeframe: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Trial details
NCT IDNCT06103396
SponsorInstituto Venezolano de Investigaciones Cientificas