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NCT04064957
Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Spinal Cord Injury
trial testing HB-adMSCs in Spinal Cord Injuries. No longer available.
Quick facts
| Lead sponsor | Hope Biosciences Research Foundation |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 1 location across United States |
Drugs / interventions tested
- HB-adMSCs — full drug profile →
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
Sponsor
Hope Biosciences Research Foundation
Who can join
18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging Landscape of Mesenchymal Stem Cell Senescence Mechanisms and Implications on Therapeutic Strategies.
Wang J, Zhang M, Wang H. · · 2024 · cited 13× · PMID 39144566 · DOI 10.1021/acsptsci.4c00284 -
Adipose-Derived Stem Cell Therapy in Spinal Cord Injury.
El Masri J, Fadlallah H, Al Sabsabi R, Afyouni A, et al · · 2024 · cited 5× · PMID 39273075 · DOI 10.3390/cells13171505
Verify or expand the search:
- PubMed search for NCT04064957
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HB-adMSCs
Trials testing the same drug.
- NCT05116540 — Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis · Phase 2 · completed
- NCT04928287 — Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate) · Phase 2 · completed
- NCT04348435 — A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19. · Phase 2 · completed
- NCT04349631 — A Clinical Trial to Determine the Safety and Efficacy of HB-adMSCs to Provide Protection Against COVID-19 · Phase 2 · completed
- NCT04228666 — A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-a · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
- NCT07109804 — Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury · NA · recruiting
- NCT07472985 — Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial · NA · recruiting
- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other Hope Biosciences Research Foundation trials
Trials by the same sponsor.
- NCT05126563 — Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome · Phase 2 · completed
- NCT05116540 — Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis · Phase 2 · completed
- NCT04995081 — Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD) · Phase 2 · completed
- NCT04928287 — Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate) · Phase 2 · completed
- NCT04362189 — Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19 · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04064957 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hope Biosciences Research Foundation
- Last refreshed: 29 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04064957.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing