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

NCT04064957 | Unknown

• 1 other identifier: HBSCI02, HBSCI04, HBSCI05
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; MSCs; HB-adMSCs; chronic SCI; stem cells; autologous

Interventions

HB-adMSCs BIOLOGICAL

Also known as: Hope Biosciences autologous adipose-derived mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• Adult individual 18 years of age or older.
• Cognitively intact and capable of giving informed consent.
• Clinical diagnosis of Spinal Cord Injury.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77474, United States

Location

Related Links

• Hope Biosciences
• Hope Biosciences Stem Cell Research Foundation

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Djamchid Lotfi, MD

  Hope Biosciences Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 22, 2019
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)