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Clinical Trials/NCT03067857
NCT03067857UnknownPhase 1

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

Stem Cells Arabia0 sites40 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Enrollment
40
Primary Endpoint
Changes in Functional Rating Scale - via questionnaire

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
24 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Stem Cells

Experimental

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

Intervention: Stem Cells (Biological)

Outcomes

Primary Outcomes

Changes in Functional Rating Scale - via questionnaire

Time Frame: 6 months

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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