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Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis

NCT04849065 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-04-19

No results posted yet for this study

Summary

Our working hypothesis is that the injection of autologous bone marrow mononuclear cells (BMNC) has a positive effect on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with ALS during the evolution of the disease

Conditions

  • ALS (Amyotrophic Lateral Sclerosis)

Interventions

DRUG

MNC (Mononuclear cells)

* Intramuscular infusion of autologous BM CMN into the TA muscle of one of the lower limbs (experimental side) * Intramuscular infusion of saline solution (placebo) in the TA muscle of the contralateral lower limb (control side)

DRUG

Placebo / Saline

\- Intramuscular infusion of saline solution (placebo) in the TA muscle of the contralateral lower limb (control side)

Sponsors & Collaborators

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-05-01
Completion
2023-09-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849065 on ClinicalTrials.gov