Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)

NCT ID: NCT01860417

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-21
• Study Completion Date: 2015-12-15

Brief Summary

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). The trial is based in previous results with autologous MSC (Orozco et al., Transplantation 92: 822-828; 2011). 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, Investigational medicinal product Num. 10-134). The assay consists of two arms with 12 patients each one. Patients in the experimental arm will be given a single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We shall follow the evolution of pain, disability and quality of life as well as disc fluid content by Magnetic Resonance Imaging (T2-calibrated).

Conditions

Degenerative Disc Disease; Intervertebral Disc Disease; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Allogenic Mesenchymal Stromal Cells

Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intradiscal injection of 25 millions MSC in 2 ml of saline

Group Type: EXPERIMENTAL

Allogenic Mesenchymal Stromal Cells

Intervention Type: BIOLOGICAL

Mepivacaine

Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine

Group Type: ACTIVE_COMPARATOR

Mepivacaine

Intervention Type: DRUG

Interventions

Allogenic Mesenchymal Stromal Cells

Intervention Type: BIOLOGICAL

Mepivacaine

Intervention Type: DRUG

Other Intervention Names

Mesenchymal stem cells (MSC); MSC injection; MSV (MSV=MSC prepared following Valladolid IBGM procedure); Sham-treated comparator; Mepivacaine is also known as Carbocaine; Mepivacaine is also known as Polocaine

Eligibility 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) image (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Citospin

INDUSTRY

Sponsor Role: collaborator

University of Valladolid

OTHER

Sponsor Role: collaborator

Red de Terapia Celular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Garcia-Sancho, MD, PhD

Role: STUDY_CHAIR

Scientific Park Foundation of University of Valladolid

David C Noriega, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clinico Universitario, Valladolid

Ana Sanchez, MD, PhD

Role: STUDY_DIRECTOR

Citospin

FRancisco Ardura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico Universitario, Valladolid

Locations

Hospital Clinico Universitario

Valladolid, , Spain

Instituto de Biologia y Genetica Molecular

Valladolid, , Spain

Countries

Spain

References

Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15.

Reference Type: BACKGROUND

PMID: 21792091 (View on PubMed)

Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Sanchez A, Garcia-Sancho J. Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1945-1951. doi: 10.1097/TP.0000000000001484.

Reference Type: DERIVED

PMID: 27661661 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/?term=orozco+and+garcia-sancho

Treatment of Degenerative Disc Disease with Autologous Mesenchymal Stem Cells

http://www.ibgm.med.uva.es

Instituto de Biologia y Genética Molecular IBGM), Cell Production Research

http://www.ncbi.nlm.nih.gov/mesh/?term=intervertebral

Intervertebral disk

http://www.ncbi.nlm.nih.gov/mesh?term=cell%2C%20mesenchymal%20stem

mesenchymal stem cells

Other Identifiers

2012-004444-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Disc_allo_MSV

Identifier Type: OTHER

Identifier Source: secondary_id

TerCel005

Identifier Type: -

Identifier Source: org_study_id