Traumatic brain injury caused by closed head trauma can lead to long-lasting cognitive, physical, and emotional challenges, and many individuals experience limited improvement with current standard treatments. Researchers are studying new approaches that may support brain function and recovery long after the initial injury has occurred.

This study evaluates the safety and potential benefits of autologous adipose-derived mesenchymal stem cells, which are created using fat cells taken from the participant’s own body. Participants will undergo detailed brain imaging, neuropsychological testing, and medical evaluations over time to help researchers understand whether this investigational treatment may improve outcomes for individuals living with chronic TBI.

You may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

• Diagnosed with traumatic brain injury
• Ages 18-55
• Able to communicate verbally

Exclusion Criteria:

• Known intellectual or psychiatric conditions, pre-injury
• Alcohol dependency
• Renal or hepatic irregularities, HIV, cancer, or prosthetic heart valves
• Previous stem cell treatments

At the end of the trial, based on evidence of benefit, Hope Biosciences may offer subjects in the placebo group the HB-adMSC infusions under an expanded access protocol.

If you choose to participate and qualify after screening, your involvement may include:

1. Initial screening and health evaluations, including blood tests and a chest X-ray

2. A minor procedure with a plastic surgeon to collect fat cells from the abdomen or flank

3. Baseline assessments, including neuropsychological testing, physical exams, MRI and PET scans, and blood draws

4. Three infusion visits (about two weeks apart), where you will receive either the investigational stem cell product or a placebo through an IV

5. Follow-up visits at six months, repeating testing and imaging to assess changes

6. A one-year in-person evaluation and a final follow-up phone call one year later

Participation includes approximately eight in-person visits over 14 months.

At the end of the trial, based on evidence of benefit, Hope Biosciences may offer subjects in the placebo group the HB-adMSC infusions under an expanded access protocol.

Snacks may be provided during visits, and transportation options once in San Antonio can be discussed. Any unexpected or medically significant findings from bloodwork or chest X-rays will be shared with participants.

At the end of the trial, based on evidence of benefit, Hope Biosciences may offer subjets in the placebo group the HB-adMSC infusions under an expanded access protocol.

There is no cost for you to participate in our research study.