Safety Study of Mesenchymal Stem Cells and Spinal Fusion (NCT01552707) | Clinical Trial Compass
CompletedPhase 1/2
Safety Study of Mesenchymal Stem Cells and Spinal Fusion
Spain69 participantsStarted 2012-07-19
Plain-language summary
The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest.
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.
Who can participate
Age range
18 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:
* L4-L5 degenerative spondylolisthesis grade I-II Meyerding isolated or associated to more than one level, and/or L4-L5 degenerative discopathy isolated or associated to more than one level.
* 18 to 85 years of age (male and female)
* Informed Consent Form signed
* The patient is able to understand the nature of the study
Exclusion Criteria:
* Previous spine surgery
* L4 isthmic spondylolisthesis
* Smoker (more than 10 cigarettes a day)
* Systemic or local infection
* Patients treated with steroids (oral or systemic) within 3 months of entering the study, or treated with biphosphonates for more than 10 years
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
* Pregnant woman or intended to become pregnant, or breath feeding
* Neoplasia within the previous 5 years, or without remission
* Immunosuppressive states (except diabetes mellitus. Treatment with therapies is allowed)
* Significant abnormal laboratory tests that contraindicates the surgery.
* Participation in another clinical trial or treated with an investigational medicinal product the previous 3 months
* 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
* The patient is legally dependent
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
safety of XCEL-MT-OSTEO-ALPHA (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)
Timeframe: 12 months
2
Feasibility of XCEL-MT-OSTEO-ALPHA (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)