Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
March 29, 2017 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Phase I/II Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Murcia
-
El Palmar, Murcia, Spain
- Hospital Universitario Virgen de la Arrixaca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Autologous bone marrow stem cells intraspinal transplantation
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
|
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 |
|
Experimental: Intrathecal infusion of autologous bone marrow stem cells
Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.
|
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. |
|
Placebo Comparator: Intrathecal infusion of placebo (saline solution).
Patients were infused 2 ml of saline solution
|
Patients were infused 2 ml of saline solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Forced vital capacity
Time Frame: Every 3 months
|
Every 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Neurological variables: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS), Medical Research Council (MRC) and Norris scales
Time Frame: Every 3 months
|
Every 3 months
|
|
Absence of adverse events
Time Frame: Every week / month depending on the study phase
|
Every week / month depending on the study phase
|
|
Neurophysiological variables: Electromyography, polysomnography, evoked potentials
Time Frame: Every 3 months
|
Every 3 months
|
|
Neuroradiological variables: Spinal Magnetic Resonance Imaging (MRI)
Time Frame: Every 3 months
|
Every 3 months
|
|
Respiratory variables: Maximal inspiratory pressure (PIM), Maximal expiratory pressure (PEM), sniff nasal, oxymetry.
Time Frame: Every 3 months
|
Every 3 months
|
|
Psychological variables: Health Questionnaire (EuroQol-5D), The Profile of Mood States (POMS)
Time Frame: Every 3 months
|
Every 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jose María Moraleda Jiménez, M.D. PhD., Hospital Universitario Virgen de la Arrixaca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
November 20, 2015
Study Completion (Actual)
November 20, 2015
Study Registration Dates
First Submitted
December 3, 2010
First Submitted That Met QC Criteria
December 3, 2010
First Posted (Estimate)
December 6, 2010
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 29, 2017
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Extension CMN/ELA
- 2006-003096-12 (EudraCT Number)
- EC07/90762 (Other Identifier: ISCIII)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.