Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury



Status:Recruiting
Conditions:Hospital, Women's Studies
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:October 2014
Contact:Joseph Gilbert, RN
Email:joseph.gilbert@stemcellsinc.com
Phone:719-576-0093

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A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury

This study will evaluate the safety and efficacy of human central nervous system stem cell
transplantation into patients with traumatic injury in the cervical region of the spinal
cord.


Inclusion Criteria:

- Male or female subjects age 18 to 60 years.

- Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the
International Standards for Neurological Classification of Spinal Cord Injury
(ISNCSCI) as determined by the Investigator.

- American Spinal Injury Association Impairment Scale (AIS) Grades B or C

- Minimum of 12 weeks post-injury prior to Screening

Exclusion Criteria:

- History of penetrating SCI.

- MRI evidence of complete spinal cord interruption .

- Evidence of spinal instability, stenosis and/or persistent cord compression related
to the initial trauma.

- Prior participation in another investigational study within 90 days prior to
Screening.

- Previous organ, tissue, bone marrow transplantation, or gene transfer

- History of malignancy (except non-melanoma skin cancers) that require(d) radiation
and/or chemotherapy
We found this trial at
13
sites
New York, New York 10029
Principal Investigator: Thomas N. Bryce, MD
Phone: 212-824-8379
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Allan Levi, MD, PhD
Phone: 305-243-7108
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Paul Park, MD
Phone: 734-936-7469
University of Michigan Health System The University of Michigan is home to one of the...
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Baltimore, Maryland 21201
Principal Investigator: Bizhan Aarabi, MD
Phone: 410-328-5332
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Aruna Ganju, MD
Phone: 312-503-2283
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Downey, California 90242
Principal Investigator: Charles Liu, MD, PhD
Phone: 562-401-7020
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Houston, Texas 77030
Principal Investigator: Dong Kim, MD
Phone: 713-500-6936
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Houston, TX
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Milwaukee, Wisconsin 53226
Principal Investigator: Shekar Kurpad, MD, PhD
Phone: 414-805-5403
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Minneapolis, Minnesota 55414
Principal Investigator: Ann Parr, MD, PhD
Phone: 612-626-1421
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Palo Alto, California 94304
Principal Investigator: Graham Creasey, MD
Phone: 650-493-5000
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: James Harrop, MD
Phone: 215-503-5646
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Michael Munin, MD
Phone: 412-692-2084
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Salt Lake City, Utah 84132
Principal Investigator: Jeffrey Rosenbluth, MD
Phone: 801-581-5328
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