Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Phase I/II Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254539
• Other study ID #: Extension CMN/ELA
• Secondary ID: 2006-003096-12EC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 3, 2010
• Last updated: March 29, 2017
• Start date: October 2010
• Est. completion date: November 20, 2015

Study information

• Verified date: November 2015
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to assess the feasibility and the security of the intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.

Description:

Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. Moreover, the clinical trial (Study NCT00855400 on www.ClinicalTrials.gov) conducted by our research group to determine the safety and efficacy of Autologous Stem Cell transplantation in Amyotrophic Lateral Sclerosis in humans, found that this procedure is feasible and safe. Continuing with that study, we have designed a phase I/II clinical trial to check the feasibility of the intraspinal and intrathecal infusion of autologous bone marrow stem cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 20, 2015
• Est. primary completion date: November 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnose established following the World Federation of Neurology criteria

• More than 6 and less than 36 months of evolution of the disease

• Medullar onset of the disease

• More than 18 and less than 70 years old

• Forced Vital Capacity = 50%

• Total time of oxygen saturation <90% inferior to 5% of the sleeping time

• Signed informed consent

Exclusion Criteria:

• Neurological or psychiatric concomitant disease

• Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube

• Concomitant systemic disease

• Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months

• Inclusion in other clinical trials

• Unability to understand the informed consent

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Procedure:
• Laminectomy and bone marrow stem cells transplantation
Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient. T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
• Intrathecal infusion of autologous bone marrow stem cells
Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient. Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells.
• Intrathecal infusion of placebo (saline solution).
Patients were infused 2 ml of saline solution

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	Fundación Diógenes, Hospital General Universitario Morales Meseguer, Hospital Universitario Virgen de la Arrixaca, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced vital capacity		Every 3 months
Secondary	Neurological variables: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS), Medical Research Council (MRC) and Norris scales		Every 3 months
Secondary	Absence of adverse events		Every week / month depending on the study phase
Secondary	Neurophysiological variables: Electromyography, polysomnography, evoked potentials		Every 3 months
Secondary	Neuroradiological variables: Spinal Magnetic Resonance Imaging (MRI)		Every 3 months
Secondary	Respiratory variables: Maximal inspiratory pressure (PIM), Maximal expiratory pressure (PEM), sniff nasal, oxymetry.		Every 3 months
Secondary	Psychological variables: Health Questionnaire (EuroQol-5D), The Profile of Mood States (POMS)		Every 3 months

External Links

•   Amyotrophic Lateral Sclerosis
•   Spanish Cell Therapy Network