To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury - Full Text View

Sponsor:	TotipotentRX Cell Therapy Pvt. Ltd.
Collaborator:	Fortis Healthcare
Information provided by (Responsible Party):	TotipotentRX Cell Therapy Pvt. Ltd.
ClinicalTrials.gov Identifier:	NCT01490242

Purpose

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.

Condition	Intervention	Phase
Spinal Cord Injury	Other: Autologous Bone Marrow derived Stem Cells	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by TotipotentRX Cell Therapy Pvt. Ltd.:

Primary Outcome Measures:

Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: Yes ]
The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.

Secondary Outcome Measures:

Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Improvement in the functional Independence as measured by Spinal Cord Independence Measure (SCIM III). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Improvement in the pain sensation score as measured by Bryce/Ragnarsson SCI pain taxonomy (BR-SCI-PT). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Significant Changes in the muscle tone as indicated by Modified Ashworth Scale (MAS). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Improvement in the Clinical Outcome Variable Scale (COVS) score. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	October 2011
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BMSC treatment group Autologous bone marrow concentrate containing Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.	Other: Autologous Bone Marrow derived Stem Cells Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs. Other Name: Bone marrow mononuclear cells (BMMNCs)

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490242

Contacts

Contact: Yashbir Dewan, MS, MCh	91-99999-48648	ydewan@yahoo.com
Contact: Venkatesh Ponemone, PhD	91-98717-87654	ponemone@totipotentrx.com

Locations

India
Fortis Hospital	Recruiting
Noida, Uttar Pradesh, India, 201303
Contact: Yashbir Dewan, MS, MCh 91-99999-48648 ydewan@yahoo.com
Principal Investigator: Yashbir Dewan, MS, MCh
Sub-Investigator: Sanjeev Dua, MS, MCh
Sub-Investigator: Yashpal S Bundela, MS, MCh
Sub-Investigator: Venkatesh Ponemone, PhD
Sub-Investigator: Kenneth L Harris, MS
Flt. Lt. Rajan Dhall Fortis Hospital	Recruiting
New Delhi, India, 110070
Contact: Yashbir Dewan, MS, MCh 91-99999-48648 ydewan@yahoo.com
Principal Investigator: Yashbir Dewan, MS, MCh
Sub-Investigator: Venkatesh Ponemone, PhD
Sub-Investigator: Kenneth Harris, MS

Sponsors and Collaborators

TotipotentRX Cell Therapy Pvt. Ltd.

Fortis Healthcare

Investigators

Principal Investigator:	Yashbir Dewan, MS, MCh	Fortis Healthcare
Study Chair:	Yashbir Dewan, MS, MCh	Fortis Healthcare

More Information

Publications:

Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93.

Willerth SM, Sakiyama-Elbert SE. Cell therapy for spinal cord regeneration. Adv Drug Deliv Rev. 2008 Jan 14;60(2):263-76. Epub 2007 Oct 5. Review.

Moviglia GA, Varela G, Brizuela JA, Moviglia Brandolino MT, Farina P, Etchegaray G, Piccone S, Hirsch J, Martinez G, Marino S, Deffain S, Coria N, Gonzáles A, Sztanko M, Salas-Zamora P, Previgliano I, Aingel V, Farias J, Gaeta CA, Saslavsky J, Blasseti N. Case report on the clinical results of a combined cellular therapy for chronic spinal cord injured patients. Spinal Cord. 2009 Jun;47(6):499-503. Epub 2009 Feb 17.

Responsible Party:	TotipotentRX Cell Therapy Pvt. Ltd.
ClinicalTrials.gov Identifier:	NCT01490242 History of Changes
Other Study ID Numbers:	TPRX/POC/BMSC/SCI
Study First Received:	December 8, 2011
Last Updated:	December 10, 2011
Health Authority:	India: Institutional Review Board

Keywords provided by TotipotentRX Cell Therapy Pvt. Ltd.:

Spinal Cord Injury
SCI
Paraplegia
Stem cells
Autologous

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2012