Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)

NCT ID: NCT01254539

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-11-20

Brief Summary

The purpose of this clinical trial is to assess the feasibility and the security of the intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.

Detailed Description

Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. Moreover, the clinical trial (Study NCT00855400 on www.ClinicalTrials.gov) conducted by our research group to determine the safety and efficacy of Autologous Stem Cell transplantation in Amyotrophic Lateral Sclerosis in humans, found that this procedure is feasible and safe. Continuing with that study, we have designed a phase I/II clinical trial to check the feasibility of the intraspinal and intrathecal infusion of autologous bone marrow stem cells.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

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

Study Groups

Autologous bone marrow stem cells intraspinal transplantation

T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

Group Type: EXPERIMENTAL

Laminectomy and bone marrow stem cells transplantation

Intervention Type: PROCEDURE

Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.

T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

Intrathecal infusion of autologous bone marrow stem cells

Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.

Group Type: EXPERIMENTAL

Intrathecal infusion of autologous bone marrow stem cells

Intervention Type: PROCEDURE

Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.

Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.

Intrathecal infusion of placebo (saline solution).

Patients were infused 2 ml of saline solution

Group Type: PLACEBO_COMPARATOR

Intrathecal infusion of placebo (saline solution).

Intervention Type: PROCEDURE

Patients were infused 2 ml of saline solution

Interventions

Laminectomy and bone marrow stem cells transplantation

Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.

T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

Intervention Type: PROCEDURE

Intrathecal infusion of autologous bone marrow stem cells

Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.

Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.

Intervention Type: PROCEDURE

Intrathecal infusion of placebo (saline solution).

Patients were infused 2 ml of saline solution

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnose established following the World Federation of Neurology criteria
• More than 6 and less than 36 months of evolution of the disease
• Medullar onset of the disease
• More than 18 and less than 70 years old
• Forced Vital Capacity ≥ 50%
• Total time of oxygen saturation <90% inferior to 5% of the sleeping time
• Signed informed consent

Exclusion Criteria

• Neurological or psychiatric concomitant disease
• Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
• Concomitant systemic disease
• Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
• Inclusion in other clinical trials
• Unability to understand the informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role: collaborator

Hospital General Universitario Morales Meseguer

OTHER

Sponsor Role: collaborator

Diógenes Foundation

OTHER

Sponsor Role: collaborator

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose María Moraleda Jiménez, M.D. PhD.

Role: STUDY_DIRECTOR

Hospital Universitario Virgen de la Arrixaca

Locations

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Countries

Spain

Related Links

http://red-tercel.com/

Spanish Cell Therapy Network

http://www.ncbi.nlm.nih.gov/mesh/68000690

Amyotrophic Lateral Sclerosis

Other Identifiers

2006-003096-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EC07/90762

Identifier Type: OTHER

Identifier Source: secondary_id

Extension CMN/ELA

Identifier Type: -

Identifier Source: org_study_id