Mesenchymal Stromal Cells for Degenerative Meniscus Injury
Spain20 participantsStarted 2014-01-31
Plain-language summary
The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.
Who can participate
Age range
40 Years – 60 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:
* Patient between 40 and 60 years of age
* Degenerative meniscus injury grade 3 (Crues et al.)
* Indication of conservative treatment
* Normal alignment of the knee (between 3º varus and 10 º valgus)
* Patient is able to follow a rehabilitation program
* Informed consent given by the patient in writing
* Patient is able to understand the trial.
Exclusion Criteria:
* Traumatic meniscus injury
* Surgical intervention to the affected knee
* Local or systemic infection
* Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
* Significant abnormal laboratory tests that contraindicates participation in the trial.
* Pregnant women or intend to become pregnant or breast-feeding
* Neoplastic process within the previous 5 years or without complete remission.
* The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
* Legally dependant patient.
* The patient does not accept to be followed-up for a period that could exceed the clinical trial length
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.