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Trial record 1 of 1 for:    NCT02290886
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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

Tracking Information
First Submitted Date  ICMJE October 9, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date August 28, 2019
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02290886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intravenous administration of placebo
    Intervention: Other: Intravenous administration of placebo
  • Experimental: 1 million of MSC
    Intravenous administration of 1 million of MSC/ kg
    Intervention: Drug: Intravenous administration of 1 million of MSC
  • Experimental: 2 million of MSC
    Intravenous administration of 2 million of MSC/ kg
    Intervention: Drug: Intravenous administration of 2 million of MSC
  • Experimental: 4 million of MSC
    Intravenous administration of 4 million of MSC/ kg
    Intervention: Drug: Intravenous administration of 4 million of MSC
Publications * Ilieva H, Maragakis NJ. Motoneuron Disease: Clinical. Adv Neurobiol. 2017;15:191-210. doi: 10.1007/978-3-319-57193-5_7. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 27, 2018)
52
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
40
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290886
Other Study ID Numbers  ICMJE CeTMAd/ELA/2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Study Sponsor  ICMJE Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborators  ICMJE Iniciativa Andaluza en Terapias Avanzadas
Investigators  ICMJE
Study Chair: Óscar Fernández, MD Hospital Regional U. de Málaga
PRS Account Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP