Clinical Trials Logo

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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT02528071 - Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Completed NCT02891629 - Safety and Feasibility of the EyeControl Device N/A
Completed NCT02164253 - Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients Phase 2
Completed NCT00786032 - A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients N/A
Recruiting NCT03787420 - Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS. N/A
Recruiting NCT05663008 - Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis
Recruiting NCT03330353 - Chromatic Pupillometry to Assess the Melanopsin-Light Pathway in Progressive Supranuclear Palsy N/A
Active, not recruiting NCT03081338 - A Programme for Amyotrophic Lateral Sclerosis Care in Europe N/A
Active, not recruiting NCT03241784 - T-Regulatory Cells in Amyotrophic Lateral Sclerosis Phase 1
Not yet recruiting NCT04849065 - Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis Phase 2
Active, not recruiting NCT05276349 - Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
Completed NCT04090684 - Ciprofloxacin/Celecoxib Combination in Patients With ALS Phase 1
Active, not recruiting NCT04055623 - T-regulatory Cells in ALS Phase 2
Completed NCT02709330 - ALS Reversals - Lunasin Regimen Phase 2
Completed NCT03482050 - A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS) Phase 1/Phase 2