Adjunctive Mesenchymal Stem Cells for Treatment-Resistant Bipolar Depression

This study is investigating whether adding Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) can help people with treatment-resistant bipolar depression. MSCs are special cells taken from bone marrow. You would receive either the MSCs or a placebo (an inactive substance) in addition to your usual care. Researchers want to see if MSCs can improve depression symptoms, measured by a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS). The study is looking for 30 participants between 18 and 65 years old who have been diagnosed with Bipolar I or II disorder and have significant depressive symptoms. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the active treatment or a placebo, and neither you nor your doctors will know which you are receiving. It plans to enroll 30 participants.
What's involved
You would receive a single infusion of MSCs or placebo up to one week after joining the study. The main treatment period lasts eight weeks, and you will also have assessments at week 26.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at week 8 and again at week 26 after the initial treatment.

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NCT03522545

Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

Recruiting
PHASE1Ages 18–65InterventionalTreatment
The University of Texas Health Science Center, Houston
~30 participants
Updated 2025-06-22 on ClinicalTrials.gov
What's tested:Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured over baseline, week 8, week 26
Treatment-resistant Bipolar Depression
1 sites across 1 states
Texas1
  • Jair C Soares, MD, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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  • Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)baseline, week 8, week 26

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a short and reliable scale devised to be sensitive to change. Patients are rated on ten items, each of which has value ranges from 0 (the least pathology) to 6 (the most sever pathology). Sum scores range from 0 to 60, with a scoring of 20 indicating moderate and 30 severe depression. The scale is sensitive to change and covers many, but not all, symptom domains in depression.