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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Laminectomy and bone marrow stem cells transplantation
Autologous bone marrow cells collection
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Bone marrow, Stem cells, Autologous, Safety

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transplant

Arm Description

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

Outcomes

Primary Outcome Measures

Forced vital capacity

Secondary Outcome Measures

ALS-FRS, MRC and Norris scales
Absence of adverse events

Full Information

First Posted
March 3, 2009
Last Updated
December 1, 2010
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
Carlos III Health Institute, Hospital Universitario Virgen de la Arrixaca, Hospital General Universitario Morales Meseguer, Diógenes Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00855400
Brief Title
Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Acronym
CMN/ELA
Official Title
Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
Carlos III Health Institute, Hospital Universitario Virgen de la Arrixaca, Hospital General Universitario Morales Meseguer, Diógenes Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, Bone marrow, Stem cells, Autologous, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transplant
Arm Type
Experimental
Arm Description
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Intervention Type
Procedure
Intervention Name(s)
Laminectomy and bone marrow stem cells transplantation
Intervention Description
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Intervention Type
Procedure
Intervention Name(s)
Autologous bone marrow cells collection
Intervention Description
Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.
Primary Outcome Measure Information:
Title
Forced vital capacity
Time Frame
Every 3 months
Secondary Outcome Measure Information:
Title
ALS-FRS, MRC and Norris scales
Time Frame
Every 3 months
Title
Absence of adverse events
Time Frame
Every week / month depending on the study phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Maria Moraleda Jiménez, M.D. Ph.D.
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22415951
Citation
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.
Results Reference
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Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

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