Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV) (Disc_allo)
This study is ongoing, but not recruiting participants.
Sponsor:
Red de Terapia Celular
Collaborators:
Citospin
University of Valladolid
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT01860417
First received: May 18, 2013
Last updated: April 4, 2016
Last verified: April 2016
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Purpose
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, PEI 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Degenerative Disc Disease Intervertebral Disc Disease Low Back Pain |
Biological: Allogenic Mesenchymal Stromal Cells Drug: Mepivacaine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Lumbar Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Bone Marrow Mesenchymal Stromal Cells Expanded Using the Valladolid IBGM Procedure |
Resource links provided by NLM:
Further study details as provided by Red de Terapia Celular:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]Number of participants with adverse events will be used as a measure of safety and tolerability. Adverse events reported: clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
Secondary Outcome Measures:
- Pain and disability evolution [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Clinical review and questionaires (Visual Analogue Scales (VAS) and Oswestry questionnaires) at 0, 3, 6 and 12 months.
- Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (RMI) [ Time Frame: up to one year ] [ Designated as safety issue: No ]RMI density measurements in T2 weighted images performed at 0, 6 and 12 months used as an indication of disc fluid content
- Llife quality evolution (Short Form (SF)-12 questionnaire) [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]SF-12 scores at 0, 3, 3 and 12 months
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Biological: Allogenic Mesenchymal Stromal Cells
Other Names:
|
|
Active Comparator: Mepivacaine
Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine
|
Drug: Mepivacaine
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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 RMI 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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01860417
Please refer to this study by its ClinicalTrials.gov identifier: NCT01860417
Locations
| Spain | |
| Hospital Clinico Universitario | |
| Valladolid, Spain, 47003 | |
| Instituto de Biologia y Genetica Molecular | |
| Valladolid, Spain, 47003 | |
Sponsors and Collaborators
Red de Terapia Celular
Citospin
University of Valladolid
Investigators
| Study Chair: | Javier Garcia-Sancho, MD, PhD | Scientific Park Foundation of University of Valladolid |
| Study Director: | David C Noriega, MD, PhD | Hospital Clinico Universitario, Valladolid |
| Study Director: | Ana Sanchez, MD, PhD | Citospin |
| Principal Investigator: | FRancisco Ardura, MD, PhD | Hospital Clinico Universitario, Valladolid |
More Information
Additional Information:
Publications:
| Responsible Party: | Red de Terapia Celular |
| ClinicalTrials.gov Identifier: | NCT01860417 History of Changes |
| Other Study ID Numbers: | TerCel005 2012-004444-30 Disc_allo_MSV |
| Study First Received: | May 18, 2013 |
| Last Updated: | April 4, 2016 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ministry of Health |
Keywords provided by Red de Terapia Celular:
|
Degenerative Disc Disease, Intervertebral Disc Disease Low Back Pain Nucleus pulposus Stem cell Cellular therapy |
Regenerative therapy Mesenchymal stem cells Bone marrow Musculoskeletal Diseases Mesenchymal Stromal Cells (allogenic) |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Spinal Diseases Intervertebral Disc Degeneration Intervertebral Disc Displacement Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bone Diseases |
Musculoskeletal Diseases Hernia Pathological Conditions, Anatomical Mepivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on September 23, 2016