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

March 29, 2017 updated by: Red de Terapia Celular

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Clinical Universitary Hospital Virgen de la Arrixaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MNC (Mononuclear cells)

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
Biological: MNC (Mononuclear cells)

The cells are infused into the TA muscle of the lower limb randomized as Group A (experimental) intramuscularly. The infusion is made with a needle, 26 gauge, at 4 points of the TA muscle a specific depth given by the neurophysiological study. The total volume infused will be 2 ml, 0.5 ml at each point.

For infusion is as painless as possible for the patient to comply exactly with stereotactic indications of neurophysiology, the infusion was made at a uniform controlled rate and for this, the syringe is placed on a Yesargil arm, equipped with a microinjector and controlled infusion device.
Placebo Comparator: Saline
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).
Other: Saline
The placebo, 2ml of saline, will be infused like in the experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of serious and non-serious adverse events related to the use of bone marrow mononuclear cells in patients with Amyotrophic Lateral Sclerosis.
Time Frame: 24 months from baseline
24 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated number of motor units (MUNE)
Time Frame: 24 months from baseline

Several techniques for estimating the MUNE, all based on the relationship between the amplitude or area of compound muscle action potential (CMAP) and amplitude or area corresponding to a single motor unit response. The differences between the techniques are due to the different ways of estimating the amplitude of the responses for individual motor units. The study will use two techniques:

Incremental Technique: The unitary amplitude (or area) of individual motor units are calculated from the responses to increasing intensities stimuli near of intensity threshold (Dantes and McComas, 1991) Statistical technique: The unit amplitude (or area) of the individual motor units are calculated from the amplitude variations (or area) of the muscle action potential obtained in response to stimuli from a fixed intensity (Daube, 2006)
24 months from baseline
Compound muscle action potential (CMAP)
Time Frame: 24 months from baseline
CMAP is registered after supramaximal stimulation intensity (0.1-0.2 ms pulses at 1 Hz) of the common peroneal nerve at the level of the head of the fibula. The electrical stimulus is placed in a fixed position during the entire registration process. CMAP will be recorded simultaneously in 5 positions along longitudinally oriented TA muscle. To determine these 5 positions bony landmarks that are reproducible between members and between different patients will be used.
24 months from baseline
Fiber density (FD)
Time Frame: 24 months from baseline
Quantifies the average number of muscle fibers per motor unit. It is obtained from single fiber recordings made with electrodes. The average number of motor unit potentials is calculated in 20 different positions in the muscle.
24 months from baseline
Muscle force MRC (Medical Research Council) score
Time Frame: 24 months from baseline
24 months from baseline
Maximum force developed in an isometric contraction of the tibialis anterior (TA) muscle.
Time Frame: 24 months from baseline
The measurement will be done in Newtons, with a dynamometer during dorsiflexion of the foot (from certain angles).
24 months from baseline
Maximum transversal area of the tibialis anterior (TA)
Time Frame: 24 months from baseline
The area will be measured in cm2 by echography.
24 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red de Terapia Celular

Collaborators

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital Universitario Virgen de la Arrixaca
Public Health Service, Murcia
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Spanish National Health System

Investigators

  • Principal Investigator: Joaquín A Gómez Espuch, MD, Hospital Universitario Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCIM/ELA
  • 2011-004801-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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