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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03925649

Recruitment Status No longer available

First Posted April 24, 2019

Last update posted September 25, 2019

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:Spinal Cord Injury at C5-C7 Level
  • Intervention/Treatment: Drug: HB-adMSCs
  • Phase: N/A
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
  • Study Type: Expanded Access
  • Official Title: Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury
  • Study Start Date: N/A
  • Primary Completion Date: N/A
  • Study Completion Date: N/A
Outcome Measures
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers:
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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Hope Biosciences

The University of Texas Health Science Center, Houston

More Information
  • Responsible Party: Hope Biosciences
  • ClinicalTrials.gov Identifier: NCT03925649 History of Changes
  • Other Study ID Numbers: Spinal Cord Injury(SCI)
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 25, 2019
  • Last Verified: August 2019
  • Keywords provided by Hope Biosciences: SCI
    stem cells
    quadriplegia
    spinal cord injury
    paralysis
    MSCs
  • Additional relevant MeSH terms: Spinal Cord Injuries