Status:
COMPLETED
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
Lead Sponsor:
Red de Terapia Celular
Collaborating Sponsors:
Citospin
University of Valladolid
Conditions:
Degenerative Disc Disease
Intervertebral Disc Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD). The trial i...
Eligibility Criteria
Inclusion
- Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.
- Fibrous ring capable of holding the cell implantation, demonstrated by Magnetic resonance imaging (MRI) image (stages 2, 3 and 4 of Adams).
- Decrease of disc height of more than 20% (radiographic measurement in side image).
- Absence of spinal infection.
- Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.
- The patient is able to understand the nature of the study.
- Informed written consent of the patient.
Exclusion
- Age over 75 or under 18 or legally dependent
- Allergy to gentamicin, or to bovine, cattle or horse serum.
- Congenital or acquired diseases leading to spine deformations that may upset cell application.
- Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
- Modic III changes on MRI images (31).
- Overweight with body mass index (mass in Kg/size in m2) greater than 35 (obesity grade II).
- Pregnancy or breast-feeding
- Neoplasia
- Immunosuppression
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- Other conditions that may, according to medical criteria, discourage participation in the study.
Key Trial Info
Start Date :
June 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01860417
Start Date
June 21 2013
End Date
December 15 2015
Last Update
April 29 2024
Active Locations (2)
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1
Hospital Clinico Universitario
Valladolid, Spain, 47003
2
Instituto de Biologia y Genetica Molecular
Valladolid, Spain, 47003