Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV) (MSV-DISC)
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|ClinicalTrials.gov Identifier: NCT02440074|
Recruitment Status : Withdrawn (Not funded Administrative formalities not completed)
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Other: Autologous bone marrow mesenchymal stem cells||Phase 1 Phase 2|
The proposed test is based on previous animal experiments with positive results by the multidisciplinary team applicant, whose results are presented in paragraph 2.6 (group results Valladolid) and Annex I (group results Oviedo).
The investigators propose phase I-II trial with 10 patients with a common condition and difficult to solve volumetric regeneration therapies, such as bone cysts in the maxillofacial region.
Autologous mesenchymal cells isolated from a sample obtained from the cancellous bone of the tuberosity intraoral mandibular later and after expansion, will be conveyed in the matrix of autologous serum. The total process takes 6-8 weeks. After this time, perform the osteotomy and enucleation of the cyst under local anesthesia and the residual cavity is filled with bioimplant containing the MSV-H.
Once the bioimplant, there will be clinical controls at 2 weeks, 2 and 6 months, to follow the evolution of regeneration by bone cavity in panoramic radiograph and CT scan.
This project proposes a novel approach to therapy twice, combining a tissue engineering protocol (bioimplant) consisting of autologous mesenchymal cells have already been approved by the unit cell production of Valladolid (MSV-H), and a new protein matrix obtained autologous serum crosslinked in order to stimulate the regenerative capacity of maxillary cystic bone defects.
|Study Type :||Interventional|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||December 2012|
|Experimental: MSV autologous transplantation||
Other: Autologous bone marrow mesenchymal stem cells
Bone marrow collection from patient, mesenchymal cells isolation and expansion under Good Manufacturing Practice (GMP) conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by intradiscal injection.
Other Name: MSV, mesenchymal stem cells by IBGM-Valladolid protocol.
- Pain relief [ Time Frame: Change from baseline at 12 months after intervention. ]Pain is scored between 0 and 100 in Visual Analogue Scale for pain (VAS).