RecruitingPhase 1NCT03522545

Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

30 participants

Start Date

Apr 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a single infusion of donated mesenchymal stem cells (a type of healing cell) can help people with treatment-resistant bipolar depression — meaning depression that has not improved with multiple standard medications. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with Bipolar I or Bipolar II disorder - You are currently in a depressive episode with a moderate-to-severe score on a depression rating scale (MADRS score of 25 or above) - You have tried at least two mood stabilizers or antidepressants without meaningful improvement - Your blood inflammation marker (CRP) is above 5 mg/L - You are not pregnant, not breastfeeding, and using a reliable contraceptive method - You are fluent enough in English to complete the study questionnaires **You may NOT be eligible if...** - You have received a stem cell transplant in the last 6 months - You cannot attend study visits or comply with study requirements - You have a condition that would make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)

Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow

BIOLOGICALPlacebo

Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT03522545