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A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral

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ClinicalTrials.gov Identifier: NCT02290886
Recruitment Status : Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Study Description
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Brief Summary:
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).

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

Detailed Description:

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 Design
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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
Study Start Date : July 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. Complications in the place of the infusion [ Time Frame: 6 months ]
    To evaluate the safety of the intravenous administration of 3 doses of autologous

  3. 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


Secondary Outcome Measures :
  1. Changes in the progression of the disease (modifications in the scale of functionality of the ALS) [ Time Frame: 6 months ]
  2. Changes in the degree of muscular force [ Time Frame: 6 months ]
  3. Changes in the vital forced capacity [ Time Frame: 6 months ]
  4. Changes of the muscular mass estimated by Nuclear Magnetic Resonance (NMR) of the upper and low extremities [ Time Frame: 6 months ]
  5. Changes in neurophysiological parameters and of quality of life [ Time Frame: 6 months ]
  6. Need and time to tracheotomy or permanent assisted ventilation [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women and males over 18-year-old.
  2. Good understanding of the protocol and aptitude to grant the informed assent.
  3. 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.
  4. Forced vital capacity of at least 50 % of the one that would correspond to them for sex, height and age.
  5. More than 6 and less than 36 months of evolution of the disease (from the beginning of the symptoms).
  6. Possibility of obtaining, at least, 50gr of adipose tissue.
  7. Treatment with riluzole, for at least, a month before the inclusion.

Exclusion Criteria:

  1. 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).
  2. Previous therapy with stem cells.
  3. Participation in another clinical trial during 3 months previous to the entry in this trial.
  4. Any disease lymphoproliferative
  5. Tracheostomy and /or gastrostomy.
  6. Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.
  7. Hypersensitivity known to the bovine foetal whey or the gentamicin.
  8. Medical precedents of infection of the HIV or any serious condition of immunocompromised.
  9. Positive HBV or HCV serology
  10. Levels of creatinine in whey > 3.0 in subjects not submitted to haemodialysis.
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas
Investigators
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Study Chair: Óscar Fernández, MD Hospital Regional U. de Málaga
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02290886     History of Changes
Other Study ID Numbers: CeTMAd/ELA/2011
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: November 2018
Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
safety evaluation
intravenous administration
3 doses of autologous MSC
ALS
Additional relevant MeSH terms:
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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