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Stem Cell Therapy
Stem Cell Therapy for Traumatic Brain Injury
Phase 2
Recruiting
Led By Charles S Cox, MD
Research Sponsored by Hope Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Awards & highlights
Summary
This trial tests if stem cells can help adults with brain injuries or lack of oxygen to the brain heal better.
Who is the study for?
This trial is for adults aged 18-55 with chronic traumatic brain injury, who can consent and communicate in English or Spanish. They should have documented neurological damage unlikely to improve with current treatments and a moderate disability level (GOS-E score >2 and ≤6). Excluded are those with intellectual deficits, psychiatric conditions, other serious health issues, pregnancy, participation in other drug/device trials, inability to undergo PET/DT-MRI tests or follow-up visits, recent infections, HIV+, certain allergies or diseases affecting organs like the liver and kidneys.Check my eligibility
What is being tested?
The study is testing the safety and potential benefits of HB-adMSCs (stem cells derived from one's own fat tissue) given through an IV to improve brain structure and function after a traumatic brain injury. It compares this treatment against a saline solution placebo. The focus is on how well patients recover cognitively and structurally from their injuries.See study design
What are the potential side effects?
While specific side effects aren't listed for HB-adMSCs since it's under investigation, common stem cell therapy risks include infection at injection site, immune system reactions causing fever or chills; however individual experiences may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute Immature Granulocytes
Absolute Neutrophils
Absolute basophils
+34 moreSecondary outcome measures
Albumin
Behavior Rating of Executive Functions-Adult
Brief Symptom Inventory 18
+20 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Autologous Adipose Derived Mesenchymal Stem Cells
Group II: PlaceboPlacebo Group1 Intervention
Normal Saline
Find a Location
Who is running the clinical trial?
Hope BiosciencesLead Sponsor
23 Previous Clinical Trials
275 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
919 Previous Clinical Trials
324,990 Total Patients Enrolled
Charles S Cox, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
4 Previous Clinical Trials
81 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently been treated for an infection.My white blood cell count is below 3,000.My liver is not functioning properly.I have cancer.I am HIV positive.I have undergone stem cell treatment.I cannot have PET or DT-MRI scans.I am between 18 and 55 years old.I have lasting brain damage from a head injury that likely won't get better with current treatments.My condition or injury was diagnosed over 6 months ago.I can communicate in either English or Spanish.I need medication or oxygen for my lung condition.I have a bleeding disorder, such as heparin-induced thrombocytopenia.I have a genetic or metabolic disorder linked to my neurological condition.I have a spinal deformity, had spinal surgery, or a complete spinal cord injury.My kidney function is normal or only slightly reduced.I cannot commit to returning for follow-up visits.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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