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Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT02116634
Recruitment Status : Withdrawn (Because economic problems)
First Posted : April 17, 2014
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
rokhsareh meamar, Alzahra Hospital, Iran

Tracking Information
First Submitted Date  ICMJE April 6, 2014
First Posted Date  ICMJE April 17, 2014
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS [ Time Frame: every 6 months up 2 years after transplantation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02116634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
  • ALS-FRS(functional rating scale) score and EMG scale [ Time Frame: before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation ]
  • FVC (forced vital capacity)and DWSE±QoL score [ Time Frame: before transplantation and every 6 months up 2 years after transplantation ]
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 Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis
Official Title  ICMJE Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients
Brief Summary Whether the mesenchymal injection on ALS patients is effective or not?
Detailed Description After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.
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 Amyotrophic Lateral Sclerosis
Intervention  ICMJE Biological: mesenchymal stem cell
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
Study Arms  ICMJE Experimental: mesenchymal stem cell
intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
Intervention: Biological: mesenchymal stem cell
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 13, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2014)
5
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. sporadic ALS according to escorial criteria
  2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
  3. mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
  4. normal polysomnography
  5. Signed consent form

Exclusion Criteria:

  1. pregnancy or lactation,
  2. vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
  3. Hospitalization due to serious illness in the last two months
  4. survival time less than two years
  5. Hypersensitivity to any component used in the cell culture
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02116634
Other Study ID Numbers  ICMJE rokhsareh
stem cell injection in ALS ( Other Identifier: iran national science foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party rokhsareh meamar, Alzahra Hospital, Iran
Study Sponsor  ICMJE Alzahra Hospital, Iran
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: keivan basiri, MD Isfahan neurosciences research center
PRS Account Alzahra Hospital, Iran
Verification Date January 2016

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