MedTrace Logo

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

NCT01860417 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-04-29

Study results available
· View outcomes & findings →

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

Interventions

BIOLOGICAL

Allogenic Mesenchymal Stromal Cells

DRUG

Mepivacaine

Sponsors & Collaborators

  • Citospin

    collaborator INDUSTRY

  • University of Valladolid

    collaborator OTHER

  • Red de Terapia Celular

    lead INDUSTRY

Principal Investigators

  • Javier Garcia-Sancho, MD, PhD · Scientific Park Foundation of University of Valladolid

  • David C Noriega, MD, PhD · Hospital Clinico Universitario, Valladolid

  • Ana Sanchez, MD, PhD · Citospin

  • FRancisco Ardura, MD, PhD · Hospital Clinico Universitario, Valladolid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-21
Primary Completion
2015-12-15
Completion
2015-12-15

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01860417 on ClinicalTrials.gov