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

NCT02290886 | Completed Phase 1

• 1 other identifier: CeTMAd/ELA/2011
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

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).

Conditions

Amyotrophic Lateral Sclerosis

Keywords

safety evaluation; intravenous administration; 3 doses of autologous MSC; ALS

Outcome Measures

Primary Outcomes (3)

• Number of adverse serious unexpected reactions or not, attributable to the treatment (SUSSARs or SAE)

  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)

  6 months

• Complications in the place of the infusion

  To evaluate the safety of the intravenous administration of 3 doses of autologous

  6 months

• Appearance of a new neurological effect not attributable to the natural progression of this pathology

  To evaluate the safety of the intravenous administration of 3 doses of autologous

  6 months

Secondary Outcomes (6)

• Changes in the progression of the disease (modifications in the scale of functionality of the ALS)

  6 months

• Changes in the degree of muscular force

  6 months

• Changes in the vital forced capacity

  6 months

• Changes of the muscular mass estimated by Nuclear Magnetic Resonance (NMR) of the upper and low extremities

  6 months

• Changes in neurophysiological parameters and of quality of life

  6 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Intravenous administration of placebo

Other: Intravenous administration of placebo

1 million of MSC

EXPERIMENTAL

Intravenous administration of 1 million of MSC/ kg

Drug: Intravenous administration of 1 million of MSC

2 million of MSC

EXPERIMENTAL

Intravenous administration of 2 million of MSC/ kg

Drug: Intravenous administration of 2 million of MSC

4 million of MSC

EXPERIMENTAL

Intravenous administration of 4 million of MSC/ kg

Drug: Intravenous administration of 4 million of MSC

Interventions

Intravenous administration of placebo OTHER

Placebo

Intravenous administration of 1 million of MSC DRUG

1 million of MSC

Intravenous administration of 2 million of MSC DRUG

2 million of MSC

Intravenous administration of 4 million of MSC DRUG

4 million of MSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud: lead
• Iniciativa Andaluza en Terapias Avanzadas: collaborator

Study Sites (4)

Hospital Regional Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena, Servicio de Neurología

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Related Publications (1)

• Ilieva H, Maragakis NJ. Motoneuron Disease: Clinical. Adv Neurobiol. 2017;15:191-210. doi: 10.1007/978-3-319-57193-5_7.

  PMID: 28674982 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Óscar Fernández, MD

  Hospital Regional U. de Málaga

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: November 14, 2014
• Study Start: July 1, 2014
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

ES (4)