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"Individual Patient Expanded Access IND Using HB-adMSCs to Treat of Spinal Cord Injury"

Sponsor
Hope Biosciences Stem Cell Research Foundation (Other)
Overall Status
No longer available
CT.gov ID
NCT04825626
Collaborator
Hope Biosciences (Industry)
1
Location

Study Details

Study Description

Brief Summary

This Individual Patient Expanded Access IND has been created per the request of a 19-year-old man who has been diagnosed with Spinal Cord Injury.

Condition or Disease Intervention/Treatment Phase
  • Biological: HB-adMSCs

Detailed Description

Subject is a 19-year-old male who fell approximately 50 feet onto his back during a skiing accident. He suffered traumatic anterolisthesis at T10-11 with associated spinal cord transection and obliteration of the central canal. He and his family are requesting this Individual Patient Expanded Access IND with the purpose of possible restoration of nerve transmission and restoring sensation in his lower body using intravenous autologous adipose derived mesenchymal stem cells. This study will give 14 infusions of 200 million HB-adMSC's over a 52 week period.

Study Design

Study Type:
Expanded Access
Official Title:
"Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Spinal Cord Injury"

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Inclusion Criteria:

    1. Adult individual 18 years of age or older.

    2. Cognitively intact and capable of giving informed consent.

    3. Clinical diagnosis of Traumatic Spinal Cord Injury.

    4. Subject has mesenchymal stem cells banked at Hope Biosciences.

    5. The patient accepts to receive treatment and to comply with follow-up visits.

    Exclusion Criteria:

    1. Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator may increase the risks associated with study participation.

    2. Active Alcohol or Drug addiction.

    3. Participation in concurrent interventional research studies during this study.

    4. Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history.

    5. Unwillingness to return for follow-up visits.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hope Biosciences Stem Cell Research Foundation Sugar Land Texas United States 77478

    Sponsors and Collaborators

    • Hope Biosciences Stem Cell Research Foundation
    • Hope Biosciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hope Biosciences Stem Cell Research Foundation
    ClinicalTrials.gov Identifier:
    NCT04825626
    Other Study ID Numbers:
    • HBSCI03
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 5, 2022