Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Spinal Cord Injury

NO_LONGER_AVAILABLE

Conditions studied: Spinal Cord Injuries

In brief

HBSCI02: This protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about 4:30pm, slipped off a boat head-first while in the Florida Keys for a family wedding, and was immediately unable to move his legs. He discharged to Texas via air ambulance for physical rehabilitation on August 23, 2017 with a diagnosis of ASIA B (American Spinal Injury Association) C-5 SCI (spinal cord injury). HBSCI04: This Individual Patient Expanded Access IND has been created per the request of a 75-year-old man who has been diagnosed with Spinal Cord Injury. The patient requested this Expanded Access IND with the purpose of possible restoration of nerve transmission and restoring sensation in his upper and lower body using intravenous autologous adipose derived mesenchymal stem cells. HBSCI05: This Individual Patient Expanded Access IND has been created per the request of a 26-year-old man who has been diagnosed with Spinal Cord Injury. The patient is a 26-year-old male who suffered an unstable C-6 compressive fracture, crushing the vertebral body and retropulsion of a large bone fragment into the vertebral canal, stenosing 75% of spinal canal in a diving accident on 12/4/2021 in Belize City, Belize. The injury classification is C-6 Asia A injury. The injury left him with flaccid paralysis below the level of C-7 dermatome.

Key facts

Study ID

NCT04064957

Run by

Hope Biosciences Research Foundation

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult individual 18 yr. of age or older.
• Cognitively intact and capable of giving informed consent.
• Clinical diagnosis of a non-penetrating traumatic SCI to the cervical spine
• Patient and Caregiver agree to use Care Connect app or web version of VirTrial platform for virtual visits.

You may not qualify if…

• Prior history of:
• 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,
• 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
• HBSCI04:
• Inclusion Criteria:
• Adult individual 18 years of age or older.
• Cognitively intact and capable of giving informed consent.
• Clinical diagnosis of Spinal Cord Injury.
• Subject has mesenchymal stem cells banked at Hope Biosciences.
• The patient accepts to receive treatment and to comply with follow-up visits.
• Exclusion Criteria:
• 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.
• Active Alcohol or Drug addiction.
• Participation in concurrent interventional research studies during this study.
• Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
• Unwillingness to return for follow-up visits.
• HBSCI05:

Where it is running

• Hope Biosciences Stem Cell Research Foundation — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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