Plain-English translation of NCT03522545 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This study is testing whether allogeneic mesenchymal stem cells — cells derived from bone marrow that may help reduce inflammation and support brain healing — can help treat bipolar depression that hasn't responded to at least two different medication treatments. Half of the participants will receive a single infusion of the stem cells, while the other half will receive a placebo (saltwater solution), and researchers will track mood and brain function over 26 weeks to see if the treatment works.
Some people with bipolar depression don't feel better even after trying multiple standard medications, leaving them with limited options. This trial is exploring whether stem cells might offer a new pathway to help by reducing inflammation and potentially supporting recovery in the brain.
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If you enroll, you will visit the clinic to receive a single infusion of either the stem cells or placebo within one week of joining. After that, you'll continue seeing your regular psychiatrist for ongoing care, and your psychiatric medications will stay the same during the study. Researchers will check in with you at weeks 8 and 26 to measure your mood and brain function using standard questionnaires and tests. The study lasts six months total, and you can leave at any time if you and your doctor feel you need different treatment.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
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