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

July 2, 2021 updated by: Hope Biosciences

Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury

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)

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hope Biosciences

Collaborators

The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBSCI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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