Actively Recruiting
Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
Led by The University of Texas Health Science Center, Houston · Updated on 2025-06-22
30
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).
CONDITIONS
Official Title
Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Bipolar I or Bipolar II disorder as confirmed by semi-structured interviews
- Age between 18 and 65 years
- Current depressive episode with Montgomery-Åsberg Depression Rating Scale (MADRS) score of 25 or above
- Treatment resistance defined as failure to respond to two trials of mood stabilizers or antidepressants
- C-reactive protein (CRP) concentration greater than 5 mg/L
- Female participants must not be pregnant, breastfeeding, or planning pregnancy and must use reliable contraception if of childbearing potential
- Ability to provide informed consent
- Fluent in English to complete neurocognitive testing
- Signed written informed consent
You will not qualify if you...
- Receipt of MSCs transplant within the last six months
- Inability to follow study procedures
- High suicidal risk
- History of brain injury, neurologic impairment, seizure disorder requiring anti-convulsants, renal or hepatic disease with abnormal lab values, immunosuppression, HIV, splenectomy, or cancer
- Serious unstable medical conditions or conditions affecting neuropsychological assessment such as Parkinson's disease, multiple sclerosis, stroke, substance abuse
- Hemodynamic instability at time of MSCs infusion
- Positive pregnancy test at screening or baseline
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
D
Dana Razouq
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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