Clinical Trial: Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)
Brief Summary: This trial pretends to validate for clinical use a bioengineered product composed of mesenchymal stem cells produced by the Instituto de Biologia y Genetica Molecular (IBGM), Valladolid (MSV, which have already been approved by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These two groups collaborate in the present project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the medical aspects. The proposed trial is based on positive results obtained in previous animal studies performed by the present multidisciplinary team. A phase I / II clinical trial with 10 patients suffering from bone cysts in the maxillofacial region is proposed. Autologous mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity filled with the protein matrix containing the mesenchymal cells. Follow up tests will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and computerized tomography scan.
Detailed Summary:
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.
Sponsor: Red de Terapia Celular
Current Primary Outcome: Pain relief [ Time Frame: Change from baseline at 12 months after intervention. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Red de Terapia Celular
Dates:
Date Received: May 4, 2015
Date Started: June 2011
Date Completion: December 2012
Last Updated: May 6, 2015
Last Verified: May 2015
