Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease

Sponsor

Red de Terapia Celular (Industry)

Overall Status

Completed

CT.gov ID

NCT01513694

Collaborator

Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán (Other), Spanish National Health System (Other)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).

Condition or Disease	Intervention/Treatment	Phase
Intervertebral Disc Disease	Procedure: Instrumented posterolateral arthrodesis	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 4, 2017

Actual Study Completion Date :

May 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MSC seeded onto a phosphate ceramic Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.	Procedure: Instrumented posterolateral arthrodesis Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight. Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.

Arm

Intervention/Treatment

Experimental: MSC seeded onto a phosphate ceramic

Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.

Procedure: Instrumented posterolateral arthrodesis

Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight. Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical

Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
Discopathy refractory to conservative treatment (drugs, physical therapy.)
Evolution greater than or equal to 6 months. Radiological
Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
NMR: grades IV and V of Pfirman.

Exclusion Criteria:

Rejection of surgical treatment.
Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
Immunosuppressive treatment.
Congenital or acquired anatomical abnormality that prevents the surgical procedure.
Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
High surgical risk (ASA> IV), or contraindication to anesthesia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trauma Service. Hospital Universitario de Salamanca	Salamanca	Castilla-León	Spain	37007

Sponsors and Collaborators

Red de Terapia Celular
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Red de Terapia Celular

ClinicalTrials.gov Identifier:

NCT01513694

Other Study ID Numbers:

CSM/Fusión/2009

First Posted:

Jan 20, 2012

Last Update Posted:

Jun 2, 2017

Last Verified:

May 1, 2017

Keywords provided by Red de Terapia Celular

Mesenchymal Stem Cells

Stem Cells

Intervertebral disc disease

Additional relevant MeSH terms:

Spinal Diseases

Intervertebral Disc Degeneration

Study Results

No Results Posted as of Jun 2, 2017