Phase 1 Bipolar Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with Bipolar I or Bipolar II disorder, confirmed through a structured clinical interview
- People between 18 and 65 years of age
- People currently experiencing a depressive episode that scores 25 or above on a standard depression rating scale (MADRS)
- People whose depression has not responded to at least two previous medication trials (across their lifetime) using mood stabilisers or antidepressants — where each trial lasted at least 6 weeks at an appropriate dose, or where the person was unable to complete a 6-week trial
- People with a blood inflammation marker (CRP) measured above 5 mg/L
- Female participants who are not pregnant, not breastfeeding, and not planning to become pregnant during the study, and who are using a reliable form of contraception if they are of childbearing age
- People who a clinician considers capable of giving informed consent
- People who have signed a written consent form
- People who are sufficiently fluent in English to complete cognitive and psychological testing
Who may not be able to join:
- People who have had a stem cell (MSC) transplant within the last six months
- People who would be unable to follow the study procedures
- People whom a clinician considers to be at high risk of suicide
- People with a history of brain injury, neurological conditions, seizure disorders requiring medication, significant kidney problems, significant liver problems, a weakened immune system, HIV, removal of the spleen, or cancer
- People with unstable serious physical health conditions, including abnormal lab results, or conditions that affect cognitive testing such as Parkinson's disease, multiple sclerosis, stroke, or alcohol and substance use disorders
- People with other serious medical conditions that, in the investigator's opinion, are not adequately managed and would prevent safe participation in the trial
- People who have unstable blood pressure or circulation at the time of the stem cell infusion
- People who test positive for pregnancy at the screening or baseline visit
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Jair C Soares, MD, PhD, The University of Texas Health Science Center, Houston
Phone: (713) 486-2523
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.