Trial record 2 of 42 for:    lumbar stem cell

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

This study has been withdrawn prior to enrollment.
(Not funded Administrative formalities not completed)
Sponsor:
Collaborators:
Instituto de Salud Carlos III
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT02440074
First received: May 4, 2015
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Degenerative Disc Disease
Other: Autologous bone marrow mesenchymal stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)

Further study details as provided by Red de Terapia Celular:

Primary Outcome Measures:
  • Pain relief [ Time Frame: Change from baseline at 12 months after intervention. ] [ Designated as safety issue: No ]
    Pain is scored between 0 and 100 in Visual Analogue Scale for pain (VAS).


Enrollment: 0
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT02440074     History of Changes
Other Study ID Numbers: Eudra-CT2008-001191-68, MSV-DISC-2008-01
Study First Received: May 4, 2015
Last Updated: May 6, 2015
Health Authority: Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines

Keywords provided by Red de Terapia Celular:
Lumbar pain
Mesenchymal Stem Cells

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 27, 2015