A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

NCT04063215 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: HBTBI01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

Conditions

Traumatic Brain Injury

Keywords

severe; hypoxic-ischemic encephalopathy; stroke; intracranial hemorrhage; cerebral palsy; chronic; neurological injury

Outcome Measures

Primary Outcomes (12)

• Vital Signs (Respiratory Rate)

  Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Respiratory Rate

  Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Vital Signs (Temperature)

  Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Temperature

  Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Vital Signs (Systolic Blood Pressure)

  Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Systolic Blood Pressure

  Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Vital Signs (Diastolic Blood Pressure)

  Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Diastolic Blood Pressure

  Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Vital Signs (Pulse Rate)

  Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Pulse Rate

  Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Vital Signs (Oxygen Saturation)

  Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation

  Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Vital Signs Change From Baseline (Diastolic Blood Pressure)

  Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Diastolic Blood Pressure

  Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

• Vital Signs Change From Baseline (Systolic Blood Pressure)

  Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Systolic Blood Pressure

  Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

• Vital Signs Change From Baseline (Pulse Rate)

  Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Pulse Rate

  Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

• Vital Signs Change From Baseline (Oxygen Saturation)

  Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Oxygen Saturation

  Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

• Vital Signs Change From Baseline (Respiratory Rate)

  Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Respiratory Rate

  Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

• Vital Signs Change From Baseline (Temperature)

  Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Temperature

  Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Secondary Outcomes (63)

• Interleukin 4

  Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Interleukin 2

  Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Interleukin 1-beta

  Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Interferon Gamma-induced Protein 10 (IP-10)

  Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

• Tumor Necrosis Factor Alpha

  Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Study Arms (1)

HB-adMSC

EXPERIMENTAL

HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)

Biological: HB-adMSCs

Interventions

HB-adMSCs BIOLOGICAL

Hope Biosciences autologous adipose-derived mesenchymal stem cells

HB-adMSC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adults between 18 and 55 years of age
• documented head injury with functional neurological damage to the central nervous system unlikely to improve with present standard of care approaches
• a Glasgow Outcome Scale-Extended (GOS-E) score \> 2 and ≤ 6
• onset or diagnosis of the injury or disease process greater than 6 months
• ability to obtain consent from the subject of their legally authorized representative (LAR)
• ability to speak English or Spanish \*required for validated neurocognitive outcome testing) -

You may not qualify if:

• known history of:
• intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
• recently treated infection,
• renal disease or altered renal function (screening serum creatinine \> 1.5 mg/dL),
• hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL),
• cancer,
• immunosuppression (screening WBC \< 3, 000 cells/ml),
• HIV+,
• chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
• acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation,
• bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
• known sensitivity to heparin, Lovenox, and pork products,
• individuals with mechanical prosthetic heart valves.
• individuals who have received a stem cell treatment.
• Normal brain CT/MRI exam

Sponsors & Collaborators

• Hope Biosciences LLC: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Lymphoma, Follicular; Hypoxia-Ischemia, Brain; Stroke; Intracranial Hemorrhages; Cerebral Palsy; Bronchiolitis Obliterans Syndrome; Trauma, Nervous System

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Wounds and Injuries; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes; Brain Damage, Chronic; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Results Point of Contact

• Title: Carmen Duron
• Organization: UTHealth, McGovern Medical School at Houston

maria.carmen.duron@uth.tmc.edu

7135007395

Study Officials

• Charles S Cox, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, non-randomized study to determine safety and treatment effect of three infusions of HB-adMSC (2 x 10\^8 total cells per dose) in adult patients with sub-acute or chronic neurological injury

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 21, 2019
• Study Start: January 1, 2020
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Locations

US (1)