Using stem cells to treat bipolar depression that doesn't respond to other treatments

Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

This study is testing whether stem cells can help people with bipolar depression who haven't found relief from other treatments feel better.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT03522545 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of allogeneic bone marrow-derived mesenchymal stem cells (MSCs) as an adjunctive treatment for patients with treatment-resistant bipolar depression. It is a randomized, double-blind, placebo-controlled study where participants will receive either MSCs or a saline placebo in addition to their usual treatment. The trial lasts eight weeks, with assessments of patient outcomes and side effects conducted throughout the study and at a follow-up point 26 weeks later. Patients must meet specific criteria for treatment resistance and will not be allowed to change their psychiatric medications during the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of Bipolar I or II disorder who have not responded to at least two previous treatments.

Not a fit: Patients who have not been diagnosed with bipolar disorder or those who have not experienced treatment-resistant depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from treatment-resistant bipolar depression.

How similar studies have performed: While the use of MSCs in treating bipolar depression is a novel approach, similar studies in other conditions have shown promising results.

Eligibility criteria

Inclusion criteria:

1. Diagnosis of DSM-IV-TR of Bipolar I or Bipolar II disorder as verified by the semi-structured diagnostic interviews SCID. The diagnosis may be supported by information from significant others, and from hospital records.
2. Age: 18-65 years
3. Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above
4. Treatment resistance: None response to two trials (during lifetime) with mood stabilizers with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and/or antidepressants.

   a A trial is defined as at least 6 weeks in adequate or tolerated dose as reported by the patient, or patients that have been unable to comply with 6 weeks trials of mood stabilizer or an antidepressant.

   b None response: Less than 50% reduction in MADRS values or still meet DSM-IV-TR criteria of depressive episode
5. CRP concentration greater than 5 mg/L
6. Female subjects whom are not pregnant, not breastfeeding, and not planning on becoming pregnant during the study. Female patients of childbearing potential must be using a reliable method of contraception.
7. Patient competent to give informed consent according to the judgment of the clinician
8. Written informed consent
9. Patient sufficiently fluent in English language to ensure valid responses to psychometric testing (needed for validated neurocognitive outcomes testing)

Exclusion criteria:

1. MSCs transplant within the last six months
2. Inability to comply with study protocol
3. Patient at high suicidal risk according to clinicians' judgement
4. History of previous brain injury; neurologic impairment and/or deficit; seizure disorder requiring anti-convulsant therapy; renal disease or altered renal function as defined by serum creatinine 2x ULN at admission; hepatic disease or altered liver function as defined by SGPT \> 2 x ULN (non-contusion related), and/or T. Bilirubin 1.5 x ULN at admission; immunosuppression as defined by WBC\<3,000 cells/ml at admission; HIV, splenectomy or cancer
5. Unstable serious medical conditions, including clinically relevant laboratory abnormalities. Conditions that affect neuropsychological assessment such as Parkinson's Disease, Multiple sclerosis, stroke, alcohol and substance abuse or dependence (according to SCID or DSM-IV-TR). Other serious medical illness that is not adequately controlled and, in the investigator's opinion, would not permit the subject to be managed according to the protocol.
6. Hemodynamic instability at the time of MSCs infusion.
7. Positive pregnancy test (at screening or baseline visits).

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Jair C Soares, MD, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Dana Razouq

Conditions: Treatment-resistant Bipolar Depression, treatment-resistant bipolar depression, bipolar disorder, manic depression