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

Primary Purpose

Spinal Cord Injury.

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Transplantation of Autologous stem cell [MNCs] .
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury. focused on measuring Spinal Cord Injury stem cell

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

stem cell [ MNCs ]

Arm Description

transplantation of autologous stem cell [MNCs ]

Outcomes

Primary Outcome Measures

Improvement in overall sensory for motor control using Frankel score.

Secondary Outcome Measures

Improvement in pain sensation and Significant changes in Muscle Tones from base line
-Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale
Significant changes in Muscle Tones and Improvement in pain sensation from base line

Full Information

First Posted
February 26, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01833975
Brief Title
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury
Acronym
SCI
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury.
Keywords
Spinal Cord Injury stem cell

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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stem cell [ MNCs ]
Arm Type
Other
Arm Description
transplantation of autologous stem cell [MNCs ]
Intervention Type
Biological
Intervention Name(s)
Transplantation of Autologous stem cell [MNCs] .
Other Intervention Name(s)
Autologous stem cell[MNCs] .
Intervention Description
Intra thecal transplantation of Autologous stem cell [MNCs],100millions per dose in 3 divided doses at interval of 10 days.
Primary Outcome Measure Information:
Title
Improvement in overall sensory for motor control using Frankel score.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Improvement in pain sensation and Significant changes in Muscle Tones from base line
Time Frame
6 month
Title
-Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale
Time Frame
6 month
Title
Significant changes in Muscle Tones and Improvement in pain sensation from base line
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sachin S Jamadar, Dortho
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Smita s Bhoyar, B.A.M.S.PGCR
Phone
9372620569
Email
drsmitabhoyar@rediff.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, M.S
Organizational Affiliation
CHAITANYA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin P Jamadar, D ORTHO
Phone
8888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Anant E Bagul, MS

12. IPD Sharing Statement

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

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