Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

NCT03522545 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HSC-MS-16-0657
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Treatment-resistant Bipolar Depression

Keywords

treatment-resistant bipolar depression; bipolar disorder; manic depression

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline, week 8, week 26

Secondary Outcomes (15)

• Change in Functional impairment as assessed by the Functioning Assessment Short Test (FAST)

  baseline, week 26

• Change in Overall functioning in living as assessed by the Global Assessment of Functioning (GAF)

  baseline, week 26

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

  baseline, week 26

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

  baseline, week 26

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

  baseline, week 26

Study Arms (2)

Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) BIOLOGICAL

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

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• MSCs transplant within the last six months
• Inability to comply with study protocol
• Patient at high suicidal risk according to clinicians' judgement
• 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
• 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.
• Hemodynamic instability at the time of MSCs infusion.
• Positive pregnancy test (at screening or baseline visits).

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Jair C Soares, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Razouq

CONTACT

(713) 486-2523; Dana.Razouq@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: May 11, 2018
• Study Start: April 20, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)