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Clinical Trials/NCT03067857
NCT03067857
Unknown
Phase 1

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

Stem Cells Arabia0 sites40 target enrollmentSeptember 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Motor Neuron Disease
Sponsor
Stem Cells Arabia
Enrollment
40
Primary Endpoint
Changes in Functional Rating Scale - via questionnaire
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
August 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

Changes in Functional Rating Scale - via questionnaire

Time Frame: 6 months

Secondary Outcomes

  • Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)(4 months)
  • Change in Forced Vital Capacity (FVC)(4 months)
  • Change in Appel Scale(4 months)

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