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

NCT ID: NCT01730183

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone marrow derived stem cells

Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.

Group Type EXPERIMENTAL

Bone marrow derived stem cells

Intervention Type OTHER

Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Bone Marrow derived Mononucleated stem cell (BMMNCs)

Eligibility Criteria

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Inclusion Criteria

1. 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 ).
2. Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
3. Those provide fully informed consent.
4. The level of spinal cord injury must be below C4.

Exclusion Criteria

1. Spinal vertebral instability.
2. Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
3. ASIA Impairment Scale category other than D \& E.
4. Lactating and pregnant women.
5. Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
6. Platelet count greater than 100 thousand/µl at screening.
7. Hematocrit less than 30% prior to bone marrow aspiration.
8. Patients with major and current psychiatric illness.
9. Significant traumatic brain injury associated with the spinal cord injury.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Max Institute of Neurosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Yashbir Dewan

Consultant Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yashbir Dewan, MS, MCh

Role: PRINCIPAL_INVESTIGATOR

Max Healthcare

Yashbir Dewan, MS, MCh

Role: STUDY_CHAIR

Max Helathcare

Locations

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Max Super speciality Hospital

Dehradun, Uttrakhand, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Yashbir Dewan, MS, MCh

Role: CONTACT

Phone: +91-8800255922

Email: [email protected]

Facility Contacts

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Role: primary

References

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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. doi: 10.3727/096368908787648074.

Reference Type BACKGROUND
PMID: 19364066 (View on PubMed)

Other Identifiers

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TPSC/POC/BMSC/SCI

Identifier Type: -

Identifier Source: org_study_id

NCT01490242

Identifier Type: -

Identifier Source: nct_alias