A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral
![]() |
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: NCT02290886 |
Recruitment Status :
Completed
First Posted : November 14, 2014
Last Update Posted : April 6, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Other: Intravenous administration of placebo Drug: Intravenous administration of 1 million of MSC Drug: Intravenous administration of 2 million of MSC Drug: Intravenous administration of 4 million of MSC | Phase 1 Phase 2 |
A multicenter phase I/II Clinical trial,randomized, controlled with placebo, triple blind to evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal stem cells cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis (ALS).
40 patients will be enrolled and will be randomized into one of the following 4 arms:
- 10 patients in the control group (placebo)
- 10 patients received a dose of 1 million MSC / kg
- 10 patients received a dose of 2 million MSC / kg.
- 10 patients received a dose of 4 million MSC / kg
The follow-up phase of each patient from the cell infusion/placebo will be 6 months.
At the time that each patient completed the follow-up period (i.e., 6 months after the infusion of the cellular product or placebo), the blind will be open, and patients who have been assigned to the control group, will receive the cell product as secondary treatment. These patients will be randomized to receive each of the doses used in the first phase. From this point, they begin a second period of follow up of 6 months.
In addition, after 6 months of MSC infusion, every patient will continue in an open extension study for 36 months to assess the safety of MSC.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Phase I/II Clinical Trial, Randomized, Controlled With Placebo, Triple Blind to Evaluate Safety, and Indications of Efficiency of the Intravenous Administration of the Therapy With 3 Doses of MSC in Patients With ASL Moderated to Severe |
Actual Study Start Date : | July 2014 |
Actual Primary Completion Date : | March 2, 2022 |
Actual Study Completion Date : | March 2, 2022 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Intravenous administration of placebo
|
Other: Intravenous administration of placebo |
Experimental: 1 million of MSC
Intravenous administration of 1 million of MSC/ kg
|
Drug: Intravenous administration of 1 million of MSC |
Experimental: 2 million of MSC
Intravenous administration of 2 million of MSC/ kg
|
Drug: Intravenous administration of 2 million of MSC |
Experimental: 4 million of MSC
Intravenous administration of 4 million of MSC/ kg
|
Drug: Intravenous administration of 4 million of MSC |
- Number of adverse serious unexpected reactions or not, attributable to the treatment (SUSSARs or SAE) [ Time Frame: 6 months ]To evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal stem cells (MSC) from adipose tissue in patients with Amyotrophic lateral Sclerosis (ALS) ABSENCE of: complications in the place of the infusion, appearance of a new neurological effect not attributable to the natural progression of this pathology and adverse serious unexpected reactions or not, attributable to the treatment (SUSSARs or SAE)
- Complications in the place of the infusion [ Time Frame: 6 months ]To evaluate the safety of the intravenous administration of 3 doses of autologous
- Appearance of a new neurological effect not attributable to the natural progression of this pathology [ Time Frame: 6 months ]To evaluate the safety of the intravenous administration of 3 doses of autologous
- Changes in the progression of the disease (modifications in the scale of functionality of the ALS) [ Time Frame: 6 months ]
- Changes in the degree of muscular force [ Time Frame: 6 months ]
- Changes in the vital forced capacity [ Time Frame: 6 months ]
- Changes of the muscular mass estimated by Nuclear Magnetic Resonance (NMR) of the upper and low extremities [ Time Frame: 6 months ]
- Changes in neurophysiological parameters and of quality of life [ Time Frame: 6 months ]
- Need and time to tracheotomy or permanent assisted ventilation [ Time Frame: 6 months ]

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: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women and males over 18-year-old.
- Good understanding of the protocol and aptitude to grant the informed assent.
- Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or probable, in agreement with the criteria of "El Escorial", of the World Federation of Neurology.
- Forced vital capacity of at least 50 % of the one that would correspond to them for sex, height and age.
- More than 6 and less than 36 months of evolution of the disease (from the beginning of the symptoms).
- Possibility of obtaining, at least, 50gr of adipose tissue.
- Treatment with riluzole, for at least, a month before the inclusion.
Exclusion Criteria:
- Any concomitant disease that under investigator's criteria could concern the measures of the clinical variables of the trial (hepatic, renal or cardiac insufficiency, diabetes mellitus, etc).
- Previous therapy with stem cells.
- Participation in another clinical trial during 3 months previous to the entry in this trial.
- Any disease lymphoproliferative
- Tracheostomy and /or gastrostomy.
- Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.
- Hypersensitivity known to the bovine foetal whey or the gentamicin.
- Medical precedents of infection of the HIV or any serious condition of immunocompromised.
- Positive HBV or HCV serology
- Levels of creatinine in whey > 3.0 in subjects not submitted to haemodialysis.

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): NCT02290886
Spain | |
Hospital Regional Universitario Reina Sofía | |
Cordoba, Spain, 14004 | |
Hospital Regional Universitario de Málaga | |
Málaga, Spain, 29010 | |
Hospital Universitario Virgen Macarena, Servicio de Neurología | |
Seville, Spain, 41009 | |
Hospital Universitario Virgen del Rocío | |
Seville, Spain, 41013 |
Study Chair: | Óscar Fernández, MD | Hospital Regional U. de Málaga |
Responsible Party: | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud |
ClinicalTrials.gov Identifier: | NCT02290886 |
Other Study ID Numbers: |
CeTMAd/ELA/2011 |
First Posted: | November 14, 2014 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | April 2022 |
safety evaluation intravenous administration 3 doses of autologous MSC ALS |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |