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

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ClinicalTrials.gov Identifier: NCT03925649
Expanded Access Status : No longer available
First Posted : April 24, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Hope Biosciences

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.

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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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: HB-adMSCs
    single infusion of HB-adMSCs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925649


Locations
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United States, Texas
Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hope Biosciences
The University of Texas Health Science Center, Houston

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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:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System