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Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension 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
Intrathecal infusion of autologous bone marrow stem cells
Intrathecal infusion of placebo (saline solution).
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

18 Years - 70 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 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

Sites / Locations

  • Hospital Universitario Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Autologous bone marrow stem cells intraspinal transplantation

Intrathecal infusion of autologous bone marrow stem cells

Intrathecal infusion of placebo (saline solution).

Arm Description

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

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

Patients were infused 2 ml of saline solution

Outcomes

Primary Outcome Measures

Forced vital capacity

Secondary Outcome Measures

Neurological variables: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS), Medical Research Council (MRC) and Norris scales
Absence of adverse events
Neurophysiological variables: Electromyography, polysomnography, evoked potentials
Neuroradiological variables: Spinal Magnetic Resonance Imaging (MRI)
Respiratory variables: Maximal inspiratory pressure (PIM), Maximal expiratory pressure (PEM), sniff nasal, oxymetry.
Psychological variables: Health Questionnaire (EuroQol-5D), The Profile of Mood States (POMS)

Full Information

First Posted
December 3, 2010
Last Updated
March 29, 2017
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
Instituto de Salud Carlos III, Hospital Universitario Virgen de la Arrixaca, Hospital General Universitario Morales Meseguer, Diógenes Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01254539
Brief Title
Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
Official Title
Phase I/II Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 20, 2015 (Actual)
Study Completion Date
November 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
Instituto de Salud Carlos III, 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 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.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous bone marrow stem cells intraspinal transplantation
Arm Type
Experimental
Arm Description
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Arm Title
Intrathecal infusion of autologous bone marrow stem cells
Arm Type
Experimental
Arm Description
Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.
Arm Title
Intrathecal infusion of placebo (saline solution).
Arm Type
Placebo Comparator
Arm Description
Patients were infused 2 ml of saline solution
Intervention Type
Procedure
Intervention Name(s)
Laminectomy and bone marrow stem cells transplantation
Intervention Description
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
Intervention Name(s)
Intrathecal infusion of autologous bone marrow stem cells
Intervention Description
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
Intervention Name(s)
Intrathecal infusion of placebo (saline solution).
Intervention Description
Patients were infused 2 ml of saline solution
Primary Outcome Measure Information:
Title
Forced vital capacity
Time Frame
Every 3 months
Secondary Outcome Measure Information:
Title
Neurological variables: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS), Medical Research Council (MRC) and Norris scales
Time Frame
Every 3 months
Title
Absence of adverse events
Time Frame
Every week / month depending on the study phase
Title
Neurophysiological variables: Electromyography, polysomnography, evoked potentials
Time Frame
Every 3 months
Title
Neuroradiological variables: Spinal Magnetic Resonance Imaging (MRI)
Time Frame
Every 3 months
Title
Respiratory variables: Maximal inspiratory pressure (PIM), Maximal expiratory pressure (PEM), sniff nasal, oxymetry.
Time Frame
Every 3 months
Title
Psychological variables: Health Questionnaire (EuroQol-5D), The Profile of Mood States (POMS)
Time Frame
Every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose María Moraleda Jiménez, M.D. PhD.
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
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://red-tercel.com/
Description
Spanish Cell Therapy Network
URL
http://www.ncbi.nlm.nih.gov/mesh/68000690
Description
Amyotrophic Lateral Sclerosis

Learn more about this trial

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

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