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

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ClinicalTrials.gov Identifier: NCT03067857
Recruitment Status : Unknown
Verified June 2018 by Stem Cells Arabia.
Recruitment status was:  Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Motor Neuron Disease Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis Progressive Muscular Atrophy Progressive Bulbar Palsies Biological: Stem Cells Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
Study Start Date : September 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : August 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cells
Intravenous and Intrathecal thecal transplantation via interventional radiology of purified autologous bone-marrow derived specific stem cell populations.
 Biological: Stem Cells
Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Functional Rating Scale - via questionnaire [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in Appel Scale [ Time Frame: 4 months ]
  2. Change in SF-36 (The Short Form (36) Health Survey is a 36 Item) [ Time Frame: 4 months ]
  3. Change in Forced Vital Capacity (FVC) [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   24 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT03067857    
Other Study ID Numbers: SCA-MND1
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Atrophy
Muscular Atrophy, Spinal
Bulbar Palsy, Progressive
Sclerosis
Pathologic Processes
Atrophy
Pathological Conditions, Anatomical
Neurodegenerative Diseases
 Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Neuromuscular Manifestations
Neurologic Manifestations