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

NCT ID: NCT00855400

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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Amyotrophic Lateral Sclerosis Bone marrow Stem cells Autologous Safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transplant

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

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

Autologous bone marrow cells collection

Intervention Type PROCEDURE

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

Interventions

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Laminectomy and bone marrow stem cells transplantation

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

Intervention Type PROCEDURE

Autologous bone marrow cells collection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carlos III Health Institute

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

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

Principal Investigators

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Jose Maria Moraleda Jiménez, M.D. Ph.D.

Role: STUDY_DIRECTOR

Hospital Universitario Virgen de la Arrixaca

Locations

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Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status

Countries

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Spain

References

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Blanquer M, Moraleda JM, Iniesta F, Gomez-Espuch J, Meca-Lallana J, Villaverde R, Perez-Espejo MA, Ruiz-Lopez FJ, Garcia Santos JM, Bleda P, Izura V, Saez M, De Mingo P, Vivancos L, Carles R, Jimenez J, Hernandez J, Guardiola J, Del Rio ST, Antunez C, De la Rosa P, Majado MJ, Sanchez-Salinas A, Lopez J, Martinez-Lage JF, Martinez S. Neurotrophic bone marrow cellular nests prevent spinal motoneuron degeneration in amyotrophic lateral sclerosis patients: a pilot safety study. Stem Cells. 2012 Jun;30(6):1277-85. doi: 10.1002/stem.1080.

Reference Type DERIVED
PMID: 22415951 (View on PubMed)

Other Identifiers

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EudraCT number: 2006-003096-12

Identifier Type: -

Identifier Source: secondary_id

ISCIII: EC07/90762

Identifier Type: -

Identifier Source: secondary_id

CMN/ELA

Identifier Type: -

Identifier Source: org_study_id