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出境医 / 临床实验 / Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Treatment of SCI

Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Treatment of SCI

Study Description
Brief Summary:
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 Intervention/treatment
Spinal Cord Injury at C5-C7 Level Drug: HB-adMSCs

Detailed Description:
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.
Study Design
Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Individual Patients, Intermediate-size Population, Treatment IND/Protocol
Official Title: Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury
Arms and Interventions
Outcome Measures
Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 16, 2019
First Posted Date April 24, 2019
Last Update Posted Date March 25, 2021
 
Descriptive Information
Brief Title Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Treatment of SCI
Official Title Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury
Brief Summary 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)
Detailed Description 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.
Study Type Expanded Access
Expanded Access Type Individual Patients, Intermediate-size Population, Treatment IND/Protocol
Condition Spinal Cord Injury at C5-C7 Level
Intervention Drug: HB-adMSCs
single infusion of HB-adMSCs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Eligibility Criteria

Inclusion Criteria:

  • Cognitively intact, capable of giving informed consent
  • Clinical diagnosis of a non-penetrating traumatic SCI
  • Asia Impairment Scale grade of A, B, or C

Exclusion Criteria:

  1. Prior history of:

    • Brain injury
    • Recent or ongoing infection
    • Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease,
    • Neurodegenerative disorders
    • Cancer
    • Immunosuppression as defined by WBC<3,000 cells/ml at baseline screening,
    • HIV+
    • Chemical or ETOH dependency
  2. Having a contraindication to MRI scans
  3. 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
  4. Participation in other interventional research studies
  5. Unwillingness to return for follow-up visits
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03925649
Other Study ID Numbers HBSCI01
Responsible Party Hope Biosciences
Study Sponsor Hope Biosciences
Collaborators The University of Texas Health Science Center, Houston
Investigators Not Provided
PRS Account Hope Biosciences
Verification Date August 2019

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