Expanded Access Protocol for Treatment of SCI With Mesenchymal Stem Cells
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ClinicalTrials.gov Identifier: NCT03925649
Expanded Access Status :
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
The University of Texas Health Science Center, Houston
This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
Condition or disease
Spinal Cord Injury at C5-C7 Level
This is an expanded access single-dose study with the primary goal of treatment submitted at the request of an individual patient with complete C5-6 spinal cord injury (SCI) resulting in quadriplegia who does not qualify for any current clinical trials and for whom there are no other FDA approved fully restorative treatments. The overall objective of this study is to evaluate patient's response, adverse events and serious adverse events (AE/SAEs), and cell expansion characteristics of a single intravenous (IV) infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in a subject with complete SCI resulting in quadriplegia.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Cognitively intact, capable of giving informed consent
Clinical diagnosis of a non-penetrating traumatic SCI
Asia Impairment Scale grade of A, B, or C
Prior history of:
Recent or ongoing infection
Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease,
Immunosuppression as defined by WBC<3,000 cells/ml at baseline screening,
Chemical or ETOH dependency
Having a contraindication to MRI scans
Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration
Participation in other interventional research studies