Allergy to gentamicin, or to bovine, cattle or horse serum.Age over 75 or under 18 or legally dependent.Informed written consent of the patient.The patient is able to understand the nature of the study.Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.Decrease of disc height of more than 20% (radiographic measurement in side image).Fibrous ring capable of holding the cell implantation, demonstrated by RMI image (stages 2, 3 and 4 of Adams).Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.Condition or diseaseĭegenerative Disc Disease Intervertebral Disc Disease Low Back Painīiological: Allogenic Mesenchymal Stromal Cells Drug: Mepivacaine
We shall follow the evolution of pain, disability and quality of life as well as disc fluid content by Magnetic Resonance Imaging (T2-calibrated). Control patients will be infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. Patients in the experimental arm will be given a single intra-discal transplantation of MSV (25 millions in 2 ml). The assay consists of two arms with 12 patients each one. Here we propose a phase I-II trial, prospective, randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing Practice (GMP)-compliant expanded bone marrow MSC (MSV, PEI Num.
#STEM CELL TREATMENT FOR DEGENERATIVE DISC DISEASE REVIEWS TRIAL#
The trial is based in previous results with autologous MSC (Orozco et al., Transplantation 92: 822-828 2011).
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). Why Should I Register and Submit Results?.
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