Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis (TCIM/ELA)

The Cellular Therapy Network (TerCel)

Status and phase: Unknown; Phase 1

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Treatments: Biological: MNC (Mononuclear cells); Other: Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02286011

2011-004801-25 (EudraCT Number)

TCIM/ELA

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)
• The patient must fulfill all inclusion criteria.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

MNC (Mononuclear cells)

Experimental group

Description:

All patients included in the clinical trial will receive an intramuscular infusion of autologous mononuclear cells (MNC) of Bone Marrow (BM) in TA muscle of one of the lower limb (experimental group). The lower limb on the CMN infuse autologous BM will be determined randomly. The average dose is 550 millions of cells (100-1200 million) diluted in 2 ml. saline

Treatment:

Biological: MNC (Mononuclear cells)

Saline

Placebo Comparator group

Description:

All patients included in the clinical trial will receive an intramuscular infusion of 2 mL of saline (placebo) in the TA muscle of the contralateral limb (group control).

Treatment:

Other: Saline