- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730183
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (ABSCI)
November 15, 2012 updated by: Yashbir Dewan, Max Institute of Neurosciences
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal cord injury patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis and the projected data related to the burden of spinal cord injuries across the globe is quite alarming.
Pharmacological and rehabilitation therapies to SCI have got limited effect.
There is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully.
Another promising therapeutic approach for SCI is "Stem cell transplantation".
Bone marrow derived stem cells have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing, axonal regeneration, and remyelination.
In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted intrathecally into patients with spinal cord injury.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yashbir Dewan, MS, MCh
- Phone Number: +91-8800255922
- Email: dr.ydewanneuro@gmail.com
Study Locations
-
-
Uttrakhand
-
Dehradun, Uttrakhand, India, 248001
- Recruiting
- Max Super Speciality Hospital
-
Contact:
- Phone Number: +91-8800255922
- Email: dr.ydewanneuro@gmail.com
-
Principal Investigator:
- Yashbir Dewan, MS, MCh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Traumatic injury of the spinal cord (below C5 level) occurring within 6 months to 8 years prior to treatment, resulting in a sustained and complete / Partial loss of sensory and motor function below the injury (ASIA Category A, B and C ).
- Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
- Those provide fully informed consent.
- The level of spinal cord injury must be below C4.
Exclusion Criteria:
- Spinal vertebral instability.
- Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
- ASIA Impairment Scale category other than D & E.
- Lactating and pregnant women.
- Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
- Platelet count greater than 100 thousand/µl at screening.
- Hematocrit less than 30% prior to bone marrow aspiration.
- Patients with major and current psychiatric illness.
- Significant traumatic brain injury associated with the spinal cord injury.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bone marrow derived stem cells
Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.
|
Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events as a measure of safety and tolerability.
Time Frame: 18 months
|
The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
Time Frame: 18 months
|
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yashbir Dewan, MS, MCh, max healthcare
- Study Chair: Yashbir Dewan, MS, MCh, Max Helathcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
November 1, 2014
Study Completion (Anticipated)
November 1, 2014
Study Registration Dates
First Submitted
November 15, 2012
First Submitted That Met QC Criteria
November 15, 2012
First Posted (Estimate)
November 21, 2012
Study Record Updates
Last Update Posted (Estimate)
November 21, 2012
Last Update Submitted That Met QC Criteria
November 15, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPSC/POC/BMSC/SCI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
-
Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
-
Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
-
NervGen PharmaRecruitingSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
-
The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
-
S.Biomedics Co., Ltd.Yonsei University; Linical Co., Ltd.RecruitingSpinal Cord Injury, Acute | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C4 Level With Complete LesionKorea, Republic of
-
Mahidol UniversityRecruitingSpinal Cord Injury | Incomplete Spinal Cord InjuryThailand
-
Kessler FoundationNew Jersey Commission on Spinal Cord ResearchRecruitingSpinal Cord Injuries | Incomplete Spinal Cord InjuryUnited States
Clinical Trials on Bone marrow derived stem cells
-
Al-Azhar UniversityHassan , Hosny , M.D. M.Sc; Samour , Hany M.D. M.Sc; Ismail , Mahmoud M.D. M.Sc; Higazy , Hasan M.D. M.Sc and other collaboratorsUnknownAge Related Macular DegenerationEgypt
-
Royan InstituteTehran University of Medical SciencesCompletedKnee OsteoarthritisIran, Islamic Republic of
-
Silesian School of MedicineMinistry of Science and Higher Education, PolandCompletedMyocardial InfarctionPoland
-
TCA Cellular TherapySuspendedAmyotrophic Lateral SclerosisUnited States
-
Hadassah Medical OrganizationCompletedMultiple Sclerosis
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingMesenchymal Stem Cells | Chronic PancreatitisUnited States
-
The Cleveland ClinicWithdrawnFistula | Crohn's Disease | Anal Fistula | Pouch, Ileal | Pouches, Ileoanal
-
University of California, IrvineWithdrawn
-
TCA Cellular TherapySuspendedSpinal Cord InjuryUnited States
-
Leiden University Medical CenterCompleted