Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 36 for:    stem cell Spinal Cord Injury AND transplantation

Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury (SCI)

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: NCT01833975
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
First Posted : April 17, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE April 17, 2013
Last Update Posted Date September 17, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2013)
Improvement in overall sensory for motor control using Frankel score. [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01833975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2013)
  • Improvement in pain sensation and Significant changes in Muscle Tones from base line [ Time Frame: 6 month ]
  • -Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale [ Time Frame: 6 month ]
  • Significant changes in Muscle Tones and Improvement in pain sensation from base line [ Time Frame: 6 month ]
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 Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury
Official Title  ICMJE Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury . It is Self Funded (Patients' Own Funding) Clinical Trial
Brief Summary This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
Detailed Description A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.[1] Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence.[2][3] Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.Injuries at any level can cause:Increased muscle tone (spasticity),Loss of normal bowel and bladder control (may include constipation, incontinence, bladder spasms),Numbness,Sensory changes Pain,Weakness, paralysis. This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
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 Spinal Cord Injury.
Intervention  ICMJE Biological: Transplantation of Autologous stem cell [MNCs] .
Intra thecal transplantation of Autologous stem cell [MNCs],100millions per dose in 3 divided doses at interval of 10 days.
Other Name: Autologous stem cell[MNCs] .
Study Arms  ICMJE stem cell [ MNCs ]
transplantation of autologous stem cell [MNCs ]
Intervention: Biological: Transplantation of Autologous stem cell [MNCs] .
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 15, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient should suffer from Spinal cord injury.
  • willingness to undergo bone marrow derived autologous cell therapy.
  • patient those provide fully Informed consent form for the study.
  • Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
  • traumatic Injury of spinal cord with complete or partial damage by MRI and Spinal cord injury level should be below C4

Exclusion Criteria:

  • Patient with pre- existing or current systemic disease such as Lung, liver,(exception:history of uncomplicated hepatitis A)gastrointestinal,cardiac , immunodeficiency(HIV)
  • History of life threatening allergic or immune - mediated reaction.
  • haemodynamically unstable patients.
  • patient suffer from peripheral muscular dystrophy.
  • lactating and pregnant woman
  • alcohol drug abuse /dependence
  • positive test result for hepatitis A and Hepatitis B OR C
  • Major-traumatic brain injury and patient with psychiatric illness .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01833975
Other Study ID Numbers  ICMJE 00103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sachin Jamadar, Chaitanya Hospital, Pune
Study Sponsor  ICMJE Chaitanya Hospital, Pune
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL
PRS Account Chaitanya Hospital, Pune
Verification Date September 2014

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