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

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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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury. Biological: Transplantation of Autologous stem cell [MNCs] . Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
stem cell [ MNCs ]
transplantation of autologous stem cell [MNCs ]
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] .




Primary Outcome Measures :
  1. Improvement in overall sensory for motor control using Frankel score. [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Improvement in pain sensation and Significant changes in Muscle Tones from base line [ Time Frame: 6 month ]
  2. -Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale [ Time Frame: 6 month ]
  3. Significant changes in Muscle Tones and Improvement in pain sensation from base line [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833975


Contacts
Contact: sachin S Jamadar, Dortho +918888788880 sac2751982@gmail.com
Contact: Smita s Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
India
Chaitanya Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin P Jamadar, D ORTHO    8888788880    sac2751982@gmail.com   
Principal Investigator: Anant E Bagul, MS         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL

Responsible Party: Dr. Sachin Jamadar, C0- Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01833975     History of Changes
Other Study ID Numbers: 00103
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
Spinal Cord Injury stem cell

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System