RECRUITING

Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

Conditions

Treatment-resistant Bipolar Depression bipolar disorder manic depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

Quick Facts

Study Start:2022-04-20

Study Completion:2024-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03522545

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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)	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).

Inclusion Criteria

Exclusion 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.
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)

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).

Contacts and Locations

Study Contact

Dana Razouq

CONTACT

(713) 486-2523

Dana.Razouq@uth.tmc.edu

Principal Investigator

Jair C Soares, MD, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Jair C Soares, MD, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-20

Study Completion Date2024-12-01

Study Record Updates

Study Start Date2022-04-20

Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

treatment-resistant bipolar depression
bipolar disorder
manic depression

Additional Relevant MeSH Terms

Treatment-resistant Bipolar Depression