Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (CMN/ELA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00855400 |
Recruitment Status
:
Completed
First Posted
: March 4, 2009
Last Update Posted
: December 2, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Procedure: Laminectomy and bone marrow stem cells transplantation Procedure: Autologous bone marrow cells collection | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Transplant
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
|
Procedure: Laminectomy and bone marrow stem cells transplantation
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Procedure: Autologous bone marrow cells collection
Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.
|
- Forced vital capacity [ Time Frame: Every 3 months ]
- ALS-FRS, MRC and Norris scales [ Time Frame: Every 3 months ]
- Absence of adverse events [ Time Frame: Every week / month depending on the study phase ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855400
Spain | |
Hospital Universitario Virgen de la Arrixaca | |
El Palmar, Murcia, Spain, 30120 |
Study Director: | Jose Maria Moraleda Jiménez, M.D. Ph.D. | Hospital Universitario Virgen de la Arrixaca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Javier Júdez Gutiérrez, Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
ClinicalTrials.gov Identifier: | NCT00855400 History of Changes |
Other Study ID Numbers: |
CMN/ELA EudraCT number: 2006-003096-12 ISCIII: EC07/90762 |
First Posted: | March 4, 2009 Key Record Dates |
Last Update Posted: | December 2, 2010 |
Last Verified: | December 2010 |
Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Amyotrophic Lateral Sclerosis Bone marrow Stem cells Autologous Safety |
Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |