Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia11 enrolled

Overview

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

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. We have designed a phase I/II clinical trial to check the feasibility of this approach in humans.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Laminectomy and bone marrow stem cells transplantationPROCEDURE

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

Autologous bone marrow cells collectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 20 and less than 65 years old * Forced Vital Capacity equal or superior to 50% * Total time of oxygen saturation \<90% inferior to 2% 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

Locations (1)

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Outcomes

Primary Outcomes

Forced vital capacity

Time frame: Every 3 months

Secondary Outcomes

ALS-FRS, MRC and Norris scales

Time frame: Every 3 months

Absence of adverse events

Time frame: Every week / month depending on the study phase

Data from ClinicalTrials.gov

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