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

Primary Purpose

Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Stem Cells
Sponsored by
Stem Cells Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Neuron Disease

Eligibility Criteria

24 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Stem Cells

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Changes in Functional Rating Scale - via questionnaire

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 25, 2017
    Last Updated
    June 4, 2018
    Sponsor
    Stem Cells Arabia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03067857
    Brief Title
    Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
    Official Title
    Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    August 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stem Cells Arabia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Progressive Muscular Atrophy, Progressive Bulbar Palsies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stem Cells
    Arm Type
    Experimental
    Arm Description
    Intravenous and Intrathecal thecal transplantation via interventional radiology of purified autologous bone-marrow derived specific stem cell populations.
    Intervention Type
    Biological
    Intervention Name(s)
    Stem Cells
    Intervention Description
    Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.
    Primary Outcome Measure Information:
    Title
    Changes in Functional Rating Scale - via questionnaire
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in Appel Scale
    Time Frame
    4 months
    Title
    Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)
    Time Frame
    4 months
    Title
    Change in Forced Vital Capacity (FVC)
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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