RECRUITING

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Conditions

Traumatic Brain Injury severe intracranial hemorrhage chronic neurological injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury.

Official Title

Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury

Quick Facts

Study Start:2024-04-16

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05951777

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults between 18 and 55 years of age. 2. Documented functional neurological damage to the central nervous system from closed head trauma that is unlikely to improve with present standard of care approaches. 3. A Glasgow Outcome Scale-Extended (GOS-E) score \>2 and ≤6. 4. Onset or diagnosis of the injury or disease process greater than 6 months and \< 20 years. 5. Ability to obtain consent from the subject or their legally authorized representative (LAR). 6. Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing).	1. Known history of: 1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, psychiatric conditions prior to TBI, 2. recently treated infection, 3. renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2), 4. hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL), 5. cancer, 6. immunosuppression (screening WBC \< 3, 000 cells/ml), 7. Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis, 8. chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment, 9. acute or chronic lung disease requiring significant medication/oxygen supplementation, 10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia, 11. known sensitivity to heparin, Lovenox, and pork products, 12. individuals with mechanical prosthetic heart valves, 13. individuals who have received a stem cell treatment, gene or cellular therapy. 2. Normal brain CT/MRI exam. 3. History of spinal cord injury. 4. Diagnosed with a genetic or metabolic disorder related to the neurologic condition. 5. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation. 6. For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control. 7. Concurrent participation in interventional drug or device study. 8. Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments. 9. Metal implants including baclofen pumps that would preclude DT-MRI. 10. Unwilling or unable to return for the follow-up study visits.

Inclusion Criteria

Exclusion Criteria

1. Adults between 18 and 55 years of age.
2. Documented functional neurological damage to the central nervous system from closed head trauma that is unlikely to improve with present standard of care approaches.
3. A Glasgow Outcome Scale-Extended (GOS-E) score \>2 and ≤6.
4. Onset or diagnosis of the injury or disease process greater than 6 months and \< 20 years.
5. Ability to obtain consent from the subject or their legally authorized representative (LAR).
6. Ability to verbally communicate in English or Spanish (required for validated neurocognitive outcome testing).

1. Known history of:
1. intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior, psychiatric conditions prior to TBI,
2. recently treated infection,
3. renal disease or altered renal function (screening eGFR \< 60 mL/min/1.73m2),
4. hepatic disease or altered liver function (screening SGPT \> 150 U/L or T. Bilirubin \>1.3 mg/dL),
5. cancer,
6. immunosuppression (screening WBC \< 3, 000 cells/ml),
7. Positive infectious disease tests including HIV, Hep. B, Hep. C., and Syphilis,
8. chemical or ETOH dependency that in the opinion of the investigator would preclude enrollment,
9. acute or chronic lung disease requiring significant medication/oxygen supplementation,
10. bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
11. known sensitivity to heparin, Lovenox, and pork products,
12. individuals with mechanical prosthetic heart valves,
13. individuals who have received a stem cell treatment, gene or cellular therapy.
2. Normal brain CT/MRI exam.
3. History of spinal cord injury.
4. Diagnosed with a genetic or metabolic disorder related to the neurologic condition.
5. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation.
6. For women of childbearing potential, a positive pregnancy test at the screening visit or, for both women and men, unwillingness to comply with acceptable methods of birth control.
7. Concurrent participation in interventional drug or device study.
8. Inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments.
9. Metal implants including baclofen pumps that would preclude DT-MRI.
10. Unwilling or unable to return for the follow-up study visits.

Contacts and Locations

Study Contact

Carmen Duron, RN, MHA, BSN

CONTACT

713-500-7395

Maria.Carmen.Duron@uth.tmc.edu

Carla Mendoza, BSN, RN

CONTACT

713-500-8206

Carla.D.Wilkerson@uth.tmc.edu

Principal Investigator

Charles S Cox, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

Memorial Hermann Hospital / UTHealth McGovern Medical School at Houston

Houston, Texas, 77030

United States

The University of Texas Health Science at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Hope Biosciences

Charles S Cox, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-16

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-04-16

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

severe
intracranial hemorrhage
chronic
neurological injury

Additional Relevant MeSH Terms

Traumatic Brain Injury