Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones (NCT02230514) | Clinical Trial Compass
CompletedPhase 1/2
Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
Spain19 participantsStarted 2014-11-20
Plain-language summary
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.
Who can participate
Age range
18 Years – 65 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:
* 18 to 85 years of age (male and female)
* Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically.
* Signed Informed Consent Form
* The patient is able to understand the nature of the study
Exclusion Criteria:
* Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
* Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
* Significant abnormal laboratory tests that contraindicates patient's participation in the study.
* Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
* Smoker of more than 15 cigarettes a day
* Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
* Badly managed diabetes mellitus.
* Patients diagnosed with peripheral arterial disorders
* Previous therapeutic radiation (5 previous years) of the affected bone.
* Neoplasia within the previous 5 years, or without remission
* The patient is legally dependent
* Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
* 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.
What they're measuring
1
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures