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New treatment option for Treatment-resistant Bipolar Depression
Official title Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
ClinicalTrials.gov ID: NCT03522545
What this study is testing
What is Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)?
Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for treatment-resistant bipolar depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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 how well it works in bipolar depression...
- CRP concentration greater than 5 mg/L
You likely can't join 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...
- Unstable serious medical conditions, including clinically relevant laboratory abnormalities. Conditions that affect neuropsychological assessment...
- Hemodynamic instability at the time of MSCs infusion.
See the full eligibility criteria
- 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 how well it works in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and/or antidepressants. a A...
- CRP concentration greater than 5 mg/L
- Female people 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)
- 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...
- Unstable serious medical conditions, including clinically relevant laboratory abnormalities. Conditions that affect neuropsychological assessment such as Parkinson's Disease, Multiple sclerosis, stroke, alcohol and...
- Hemodynamic instability at the time of MSCs infusion.
- Positive pregnancy test (at screening or baseline visits).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.