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Trial record 61 of 7632 for:    stem cells

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03067857
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

Tracking Information
First Submitted Date  ICMJE February 25, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date June 5, 2018
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
Changes in Functional Rating Scale - via questionnaire [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03067857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Change in Appel Scale [ Time Frame: 4 months ]
  • Change in SF-36 (The Short Form (36) Health Survey is a 36 Item) [ Time Frame: 4 months ]
  • Change in Forced Vital Capacity (FVC) [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
Official Title  ICMJE Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Motor Neuron Disease
  • Amyotrophic Lateral Sclerosis
  • Primary Lateral Sclerosis
  • Progressive Muscular Atrophy
  • Progressive Bulbar Palsies
Intervention  ICMJE Biological: Stem Cells
Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.
Study Arms  ICMJE Experimental: Stem Cells
Intravenous and Intrathecal thecal transplantation via interventional radiology of purified autologous bone-marrow derived specific stem cell populations.
Intervention: Biological: Stem Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03067857
Other Study ID Numbers  ICMJE SCA-MND1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stem Cells Arabia
Study Sponsor  ICMJE Stem Cells Arabia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stem Cells Arabia
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP