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Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis

Phase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis.

NCT02286011•Red de Terapia Celular

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis by a prospective, single-center, randomized, parallel, double-blind, placebo-controlled phase I clinical trial.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of definite or probable ALS according to the criteria established by the World Federation of Neurology
•Patient that provides reasonable assurance of adherence to protocol.
•Neurophysiological data confirming affectation of lower motor neurons in the lumbar region.
•Assessment of motor deficits in dorsiflexion of both feet (4 or 5 points on the MRC scale)

Exclusion Criteria

•Diabetes Mellitus.
•Other diseases that may present with polyneuropathy.
•Previous history of stroke.
•Prior Pathology of the peripheral nervous system affecting one or both lower limbs with or without clinically evident neurological sequelae.
•Pregnant or breastfeeding patients active.
•Patients physiologically capable of becoming pregnant, unless they are using reliable contraception.
•Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
•Positive serology for hepatitis B, hepatitis C or HIV.
•Clinical and anesthesiologic Criteria, contraindicating either sedation or extraction of MO (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin puncture site, etc.)
•Included in other clinical trials in the last 6 months.

Locations (1)

Clinical Universitary Hospital Virgen de la Arrixaca

El Palmar, Murcia, Spain

Key Dates

Start Date

November 1, 2014

Primary Completion Date

December 1, 2017

Completion Date

December 1, 2017

Last Updated

March 30, 2017

Enrollment

ESTIMATED participants

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Interventions

MNC (Mononuclear cells)

BIOLOGICAL

Saline

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis

Inclusion Criteria

Exclusion Criteria

Omics Sciences for the Identification of Pathogenetic Mechanisms and Biomarkers in Neurodegenerative Diseases

Augmented Reality BCI Longitudinal Study for Persons With Late Stage ALS

Tongue-strengthening Exercises in People With ALS.

Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)

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