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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jair C Soares, MD, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
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What this trial measures
- 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.