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

The Cellular Therapy Network (TerCel)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Degenerative Disc Disease; Low Back Pain; Intervertebral Disc Disease

Treatments: Drug: Mepivacaine; Biological: Allogenic Mesenchymal Stromal Cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01860417

TerCel005

2012-004444-30 (EudraCT Number)

Disc_allo_MSV (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Allogenic Mesenchymal Stromal Cells

Experimental group

Description:

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

Treatment:

Biological: Allogenic Mesenchymal Stromal Cells

Mepivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Mepivacaine