Dose Escalation Study of AST-OPC1 in Spinal Cord Injury



Status:Completed
Conditions:Hospital, Orthopedic, Women's Studies
Therapuetic Areas:Orthopedics / Podiatry, Other, Reproductive
Healthy:No
Age Range:18 - 69
Updated:2/8/2019
Start Date:March 2015
End Date:December 2018

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A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury

The purpose of this study is to evaluate the safety of cross sequential escalating doses of
AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post
injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).


Major Inclusion Criteria:

- Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3

- Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5

- Last fully preserved single neurological level (SNL) from C-4 to C-7

- From 18 through 69 years of age at time of injury

- Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI)
scan, with sufficient visualization of the spinal cord injury epicenter and lesion
margins to enable post-injection safety monitoring

- Informed consent for this protocol and the companion long term follow-up protocol must
be provided and documented (i.e., signed informed consent forms) no later than 37 days
following injury

- Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days
following SCI

Major Exclusion Criteria:

- SCI due to penetrating trauma

- Traumatic anatomical transection or laceration of the spinal cord based on prior
surgery or MRI

- Any concomitant injury that interferes with the performance, interpretation or
validity of neurological examinations

- Inability to communicate effectively with neurological examiner such that the validity
of patient data could be compromised

- Significant organ damage or systemic disease that would create an unacceptable risk
for surgery or immunosuppression

- History of any malignancy (except non-melanoma skin cancers)

- Pregnant or nursing women

- Body mass index (BMI) > 35 or weight > 300 lbs.

- Active participation in another experimental procedure/intervention
We found this trial at
9
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Kurpad Shekar, MD, PhD
Phone: 414-805-7183
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Eric M Horn, MD, PhD
Phone: 317-396-1298
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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Atlanta, Georgia 30309
Principal Investigator: Donald P Leslie, MD
Phone: 800-743-7437
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Atlanta, GA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Richard G Fessler, MD, PhD
Phone: 312-563-6827
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Joseph Ciacci, MD
Phone: 844-317-7836
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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Los Angeles, California 90640
Principal Investigator: Charles Liu, MD, PhD
Phone: 562-401-7020
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Los Angeles, CA
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130 South 9th Street
Philadelphia, Pennsylvania 19107
Principal Investigator: James Harrop, MD
Phone: 215-503-9110
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Philadelphia, PA
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Saint Louis, Missouri 63110
Principal Investigator: Wilson Zack Ray, MD
Phone: 314-362-3473
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Saint Louis, MO
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450 Serra Mall
San Jose, California 95128
Principal Investigator: Gary K Steinberg, MD
Phone: 408-885-3962
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San Jose, CA
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