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

Primary Purpose

Spinal Cord Injury at C5-C7 Level

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
HB-adMSCs
Sponsored by
Hope Biosciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Spinal Cord Injury at C5-C7 Level focused on measuring SCI, stem cells, quadriplegia, spinal cord injury, paralysis, MSCs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

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

Sites / Locations

  • Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 16, 2019
Last Updated
July 2, 2021
Sponsor
Hope Biosciences
Collaborators
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03925649
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
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hope Biosciences
Collaborators
The University of Texas Health Science Center, Houston

4. Oversight

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury at C5-C7 Level
Keywords
SCI, stem cells, quadriplegia, spinal cord injury, paralysis, MSCs

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HB-adMSCs
Intervention Description
single infusion of HB-adMSCs

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
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: 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 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 Unwillingness to return for follow-up visits
Facility Information:
Facility Name
Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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