Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

Who is this study for? Patients with treatment-resistant bipolar depression
What treatments are being studied? Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

• Age: 18-65 years

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

• 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

• CRP concentration greater than 5 mg/L

• 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.

• Patient competent to give informed consent according to the judgment of the clinician

• Written informed consent

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

Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Dana Razouq
Dana.Razouq@uth.tmc.edu
(713) 486-2523
Time Frame
Start Date: 2022-04-20
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 30
Treatments
Experimental: Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal
Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow
Placebo_comparator: Placebo
Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston

This content was sourced from clinicaltrials.gov