Stem Cell Therapy for Bipolar Depression

Overseen By Dana Razouq

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Mood stabilizers

Must not be taking: Anticonvulsants

Disqualifiers: Brain injury, Renal disease, Hepatic disease, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stem cell therapy to determine its effectiveness for bipolar depression unresponsive to standard treatments. Participants will receive either the stem cell therapy (Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells, MSCs) or a placebo (inactive substance) for comparison. The trial seeks individuals diagnosed with bipolar disorder who have tried at least two different mood stabilizers or antidepressants without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for treatment-resistant bipolar depression, it might be assumed that participants are already on mood stabilizers or antidepressants.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that certain cells from donated bone marrow, called MSCs, have been studied for safety in humans. Researchers are testing these cells to see if they can help with conditions like treatment-resistant bipolar depression. Some studies have found that these cells are generally safe, with most people not experiencing serious side effects. However, since this trial is in the early stages, it primarily focuses on ensuring the treatment's safety, so unknown risks may still exist. Always discuss potential risks and benefits with the study team before joining any clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bipolar depression, such as mood stabilizers and antipsychotic medications, this new therapy uses allogeneic bone marrow derived multipotent mesenchymal stromal cells (MSCs). These MSCs are special because they are derived from donor bone marrow and have the potential to repair and regenerate damaged tissues, which is a novel approach for mental health conditions. Researchers are excited about this treatment because MSCs might offer a new way to target the biological basis of bipolar depression, potentially leading to more effective and long-lasting relief compared to current options.

What evidence suggests that this treatment might be an effective treatment for bipolar depression?

Research has shown that certain cells from donated bone marrow, called MSCs, may help treat depression. In animal studies, these cells repaired brain cells in rats by boosting proteins that support brain health. Early research in humans suggests that MSCs might reduce symptoms in people with depression that doesn't respond to other treatments. These cells likely work by reducing inflammation and helping brain cells heal. While more research is needed, initial results are promising for those with hard-to-treat bipolar depression. Participants in this trial will receive either the MSC treatment or a placebo to evaluate the effectiveness of MSCs in treating bipolar depression. ^{1 2 3 5 6}

Who Is on the Research Team?

Jair C Soares, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with treatment-resistant bipolar depression, confirmed by specific interviews and hospital records. Participants must have a CRP level over 5 mg/L, not be pregnant or breastfeeding, use contraception if applicable, and be fluent in English for testing purposes. They should have had less than a 50% reduction in depression symptoms after previous treatments.

Inclusion Criteria

I have been diagnosed with Bipolar I or II disorder.

I have been diagnosed with a severe depressive episode.

Patient sufficiently fluent in English language to ensure valid responses to psychometric testing (needed for validated neurocognitive outcomes testing)

Exclusion Criteria

Inability to comply with study protocol

You have a medical condition that is not well controlled, which may affect your ability to participate in the trial. You also have a condition that may affect your neuropsychological assessment or have a history of substance abuse.

I am stable and do not have severe fluctuations in my blood pressure or heart rate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of MSCs or placebo and continue with treatment as usual for 8 weeks

8 weeks

1 visit (in-person) for infusion

Follow-up

Participants are monitored for safety and effectiveness, including neurocognitive and clinical assessments at week 26

18 weeks

1 visit (in-person) at week 26

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests the effectiveness of Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (MSCs) against a placebo in treating bipolar depression that hasn't improved with standard treatments. The MSCs are derived from bone marrow to see if they can help alleviate depressive symptoms.

How Is the Trial Designed?

Group I: Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Hippocampal neurons derived from induced pluripotent stem cells (iPSCs) of bipolar disorder (BD) patients exhibit hyperexcitability, which is confirmed across different patient cohorts, indicating a consistent cellular characteristic of the disorder.

The study identifies two sub-populations of BD neurons based on lithium responsiveness, with lithium treatment effectively reducing hyperexcitability in lithium-responsive patients but not in non-responsive patients, highlighting the potential for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurons derived from patients with bipolar disorder divide into intrinsically different sub-populations of neurons, predicting the patients' responsiveness to lithium. Stern, S., Santos, R., Marchetto, MC., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03522545

Adjunctive Allogeneic Mesenchymal Stem Cells for ... This clinical trial is a randomized, double-blind, placebo-controlled study aiming to study the efficacy and side effects of MSCs adjunctive to TAU compared to ...

2. trial.medpath.com trial.medpath.com/clinical-trial/d64aedb1c6865113/nct03522545-adjunctive-allogeneic-mesenchymal-stem-cells-treatment-resistant-bipolar-depression

Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment ... This clinical trial is a randomized, double-blind, placebo-controlled study aiming to study the efficacy and side effects of MSCs adjunctive to TAU compared to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12428767/

The Therapeutic Potential of Stem Cells in Depression - PMC Bone marrow mesenchymal stem cells-derived exosomes improve injury of hippocampal neurons in rats with depression by upregulating microRNA ...

4. withpower.com withpower.com/trial/phase-1-depressive-disorder-5-2021-9e5f9

Stem Cell Therapy for Bipolar Depression Trial Overview The study tests the effectiveness of Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (MSCs) against a placebo in treating bipolar ...

5. trialx.com trialx.com/clinical-trials/listings/236447/adjunctive-allogeneic-mesenchymal-stem-cells-for-treatment-resistant-bipolar-depression/?&radius=50

Adjunctive Allogeneic Mesenchymal Stem Cells for ... This clinical trial is a randomized, double-blind, placebo-controlled study aiming to study the efficacy and side effects of MSCs adjunctive to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5689769/

Allogeneic Bone Marrow‐Derived Mesenchymal Stromal ... We conducted a phase II, noncomparative, multicenter study to assess the efficacy and safety of allogeneic bone marrow‐derived mesenchymal stromal cells ...