Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)

Degenerative Disc Disease Clinical Trial

— MSV-DISC  

Official title:

Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02440074
• Other study ID #: Eudra-CT2008-001191-68
• Secondary ID: MSV-DISC-2008-01
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 4, 2015
• Last updated: May 6, 2015
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: Red de Terapia Celular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and ConsumptionSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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; 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 Criteria:

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Red de Terapia Celular	Centro en Red de Medicina Regenerativa de Castilla y Leon, Instituto de Salud Carlos III, University of Valladolid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Pain is scored between 0 and 100 in Visual Analogue Scale for pain (VAS).	Change from baseline at 12 months after intervention.	No