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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03067857
• Other study ID #: SCA-MND1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: August 2019

Study information

• Verified date: June 2018
• Source: Stem Cells Arabia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Atrophy
• Motor Neuron Disease
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Primary Lateral Sclerosis
• Progressive Bulbar Palsies
• Progressive Muscular Atrophy
• Sclerosis

Intervention

Biological:
• Stem Cells
Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cells Arabia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Functional Rating Scale - via questionnaire		6 months
Secondary	Change in Appel Scale		4 months
Secondary	Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)		4 months
Secondary	Change in Forced Vital Capacity (FVC)		4 months