Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease

NCT ID: NCT03067857

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-08-31

Brief Summary

Herein, the investigators study the safety and efficacy of transplanting purified autologous bone marrow-derived stem cells transplanted via the intrathecal route by interventional radiology and the intravenous route.

Detailed Description

A motor neuron disease (MND) is any of several neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. They include amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), progressive muscular atrophy (PMA), progressive bulbar palsy (PBP) and pseudobulbar palsy; spinal muscular atrophies are also sometimes included in the group.They are neurodegenerative diseases that cause increasing disability and eventually, death.

In spite of intensive research, motor neuron diseases (MNDs) are still incurable. Some of the key factors in this failure to find a cure have been the lack of human cell-based disease models for molecular analysis and drug screening and the difficulty of obtaining homogeneous populations of specific cell types for clinical applications. Stem cell biology has the potential to transform our understanding of disease processes and to revolutionize our approach to develop novel therapies for MNDs.

In this study, the investigators suggest a protocol for the treatment of MND by transplantation of purified autologous bone marrow-derived stem cells via the intrathecal and intravenous route.

Conditions

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Progressive Muscular Atrophy; Progressive Bulbar Palsies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem Cells

Intravenous and Intrathecal thecal transplantation via interventional radiology of purified autologous bone-marrow derived specific stem cell populations.

Group Type: EXPERIMENTAL

Stem Cells

Intervention Type: BIOLOGICAL

Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.

Interventions

Stem Cells

Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients age 24-20 years old
• Patients with the diagnosis of definite Motor Neuron Disease

Exclusion Criteria

• HIV/HBV/HCV
• Malignancies
• Bleeding
• Pneumonia
• Renal failure
• liver dysfunction
• Severe anemia (hb < 8)
• Bone Marrow diseases
• Pregnancy and lactation
• Acute medical conditions/infections such as respiratory infections
• ventilatory support

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stem Cells Arabia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SCA-MND1

Identifier Type: -

Identifier Source: org_study_id