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

ALS (Amyotrophic Lateral Sclerosis) Clinical Trial

— TCIM/ELA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02286011
• Other study ID #: TCIM/ELA
• Secondary ID: 2011-004801-25
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 24, 2014
• Last updated: March 29, 2017
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Red de Terapia Celular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALS (Amyotrophic Lateral Sclerosis)
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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.

Other:
• Saline
The placebo, 2ml of saline, will be infused like in the experimental arm.

Locations

Country	Name	City	State
Spain	Clinical Universitary Hospital Virgen de la Arrixaca	El Palmar	Murcia

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Blanquer M, Moraleda JM, Iniesta F, Gómez-Espuch J, Meca-Lallana J, Villaverde R, Pérez-Espejo MÁ, Ruíz-López FJ, García Santos JM, Bleda P, Izura V, Sáez M, De Mingo P, Vivancos L, Carles R, Jiménez J, Hernández J, Guardiola J, Del Rio ST, Antúnez C, De — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of serious and non-serious adverse events related to the use of bone marrow mononuclear cells in patients with Amyotrophic Lateral Sclerosis.		24 months from baseline
Secondary	Estimated number of motor units (MUNE)	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
Secondary	Compound muscle action potential (CMAP)	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
Secondary	Fiber density (FD)	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
Secondary	Muscle force MRC (Medical Research Council) score		24 months from baseline
Secondary	Maximum force developed in an isometric contraction of the tibialis anterior (TA) muscle.	The measurement will be done in Newtons, with a dynamometer during dorsiflexion of the foot (from certain angles).	24 months from baseline
Secondary	Maximum transversal area of the tibialis anterior (TA)	The area will be measured in cm2 by echography.	24 months from baseline