What side effects are associated with this type of intervention?

Common treatments for bipolar depression include pharmacotherapy, electroconvulsive therapy (ECT), and neuromodulation techniques. Pharmacotherapy often involves mood stabilizers like lithium, which can cause side effects such as tremor, increased thirst, diarrhea, and subclinical hypothyroidism. Antidepressants and antipsychotics may lead to weight gain, metabolic syndrome, and sedation. ECT, while effective, can result in cognitive impairment and memory loss, particularly with bilateral electrode placement. Neuromodulation techniques like transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS) are generally well-tolerated but can cause mild side effects such as headache, scalp discomfort, and transient voice changes. The trial of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells aims to explore a novel treatment with potentially different side effect profiles, focusing on regenerative and immunomodulatory properties.

What prior FDA approvals exist?

The FDA has approved several treatments for Bipolar Depression, including pharmacological options like lithium, second-generation antipsychotics (e.g., quetiapine, lurasidone), and anticonvulsants (e.g., lamotrigine). Electroconvulsive therapy (ECT) is also recognized for its efficacy in treatment-resistant cases. While the use of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) is still under investigation, these cells are being studied for their potential regenerative and immunomodulatory properties, which could offer a novel approach to treating Bipolar Depression.

What other types of research exist?

Promising novel alternatives to Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells for treating bipolar depression include: 1) Human Adipose-Derived Mesenchymal Stem Cells (hAD-MSCs), which have shown potential in neurological applications such as retinal injury recovery. 2) Induced Pluripotent Stem Cells (iPSCs), which can be reprogrammed from somatic cells and have broad regenerative capabilities. 3) Human Embryonic Stem Cell (hESC)-derived progenitor cells, which have been used in various clinical trials for neurological and cardiovascular conditions. These alternatives are being explored for their regenerative and immunomodulatory properties, which could be beneficial for treatment-resistant bipolar depression.

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Multipotent Mesenchymal Stromal Cells

Stem Cell Therapy for Bipolar Depression

Phase 1

Recruiting

Led By Jair C Soares, MD, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18-65 years

Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above

Must not have

MSCs transplant within the last six months

Hemodynamic instability at the time of MSCs infusion.

Timeline

Screening 2 days

Treatment Varies

Follow Up 26 weeks

Summary

This trial uses special cells from donated bone marrow to treat patients with bipolar depression who haven't responded to standard treatments. The cells may help by reducing inflammation and promoting brain healing. This approach has shown promise in preventing depression and anxiety in animal studies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects of MSC therapy are not detailed here, common concerns may include reactions at the infusion site, potential immune responses, or infection risks due to stem cell administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with a severe depressive episode.

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My depression hasn't improved much with treatment.

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I have been diagnosed with Bipolar I or II disorder.

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I am between 18 and 65 years old.

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I have been diagnosed with a severe depressive episode.

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I haven't improved after two treatments with specific mood stabilizers or antidepressants.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant within the last 6 months.

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

Timeline

Screening ~ 2 days1 visit

Treatment ~ Varies

Follow Up ~ 26 weeks9 visits

Screening ~ 2 days

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 2 days for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary study objectives

Change in C-reactive protein (CRP) level as assessed by enzyme-linked immunosorbent assay (ELISA)

Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of depression subscale

Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of mania subscale

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Allogeneic Bone Marrow Derived Multipotent Mesenchymal StromalExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Depression include electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), and mesenchymal stem cells (MSCs). ECT works by inducing controlled seizures that can reset brain chemistry, often leading to rapid improvement in mood symptoms. TMS uses magnetic fields to stimulate nerve cells in the brain, which can help regulate mood. MSCs, particularly those derived from bone marrow, have regenerative and immunomodulatory properties. They can potentially repair damaged tissues and modulate immune responses, which may help in reducing inflammation and promoting brain health. These mechanisms are crucial for Bipolar Depression patients as they offer alternative pathways to traditional pharmacotherapy, which may not be effective for everyone.

The key role of insomnia and sleep loss in the dysregulation of multiple systems involved in mood disorders: A proposed model.Potential Use of Stem Cells in Mood Disorders.Role of Neuro-Immunological Factors in the Pathophysiology of Mood Disorders: Implications for Novel Therapeutics for Treatment Resistant Depression.