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

Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00855400

Acronym

CMN/ELA

Enrollment

Registered

2009-03-04

Start date

2007-02-28

Completion date

2010-02-28

Last updated

2010-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, Bone marrow, Stem cells, Autologous, Safety

Brief summary

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.

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

Interventions

PROCEDURELaminectomy and bone marrow stem cells transplantation

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

PROCEDUREAutologous bone marrow cells collection

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Forced vital capacity	Every 3 months

Secondary

Measure	Time frame
ALS-FRS, MRC and Norris scales	Every 3 months
Absence of adverse events	Every week / month depending on the study phase

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026