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Stem Cell Therapy for Bipolar Depression
Study Summary
This trial is testing whether a cell therapy can help people with treatment-resistant bipolar depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- I have been diagnosed with Bipolar I or II disorder.I have been diagnosed with a severe depressive episode.You have a medical condition that is not well controlled, which may affect your ability to participate in the trial. You also have a condition that may affect your neuropsychological assessment or have a history of substance abuse.I am stable and do not have severe fluctuations in my blood pressure or heart rate.I am not pregnant, breastfeeding, or planning to become pregnant and use contraception.I haven't improved after two treatments with specific mood stabilizers or antidepressants.I have no history of brain injury, seizures, serious kidney or liver issues, weak immune system, HIV, or cancer.I am between 18 and 65 years old.I have been diagnosed with a severe depressive episode.You are at high risk of attempting suicide, as determined by your doctor.I had a stem cell transplant within the last 6 months.I have been diagnosed with Bipolar I or II disorder.I am mentally capable of understanding and agreeing to the trial's procedures.I have tried a mood stabilizer or antidepressant for at least 6 weeks without success.My depression hasn't improved much with treatment.I am not pregnant, breastfeeding, or planning to become pregnant and I use birth control.My depression hasn't improved much with treatment.I am between 18 and 65 years old.
- Group 1: Placebo
- Group 2: Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal
- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 26 Weeks after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical trial have an age restriction, and if so, what is it?
"This trial only caters to patients aged 18-65. However, there are 207 studies that focus on minors and 1,051 specialised clinical trials for elderly persons."
What is the participant size for this clinical trial?
"Indeed, the clinicaltrials.gov page attests to this medical trial's current recruitment process. The study was first uploaded on June 1st 2021 and has since been updated on September 6th 2022. 30 patients need to be enrolled at a single research site for completion of the project."
Is the enrollment for this trial currently open?
"Affirmative. The clinical trial, which was made available online on June 1st 2021, is recruiting participants and can be found hosted on the website of clinicaltrials.gov. 30 individuals need to be recruited from a single medical centre for this experiment to succeed."
For whom is this clinical investigation open to participate?
"This clinical trial is in search of 30 participants between the ages of 18 and 65 presenting with manic disorder. In order to qualify, individuals must meet these prerequisites: Age (18-65 years old), Diagnosis (as established by Structured Clinical Interview for DSM Disorders - SCID) , Severity (DSM-IV-TR criteria of depressive episode and Montgomery Asberg Depression Rating Scale score of 25 or above), Non-Responders (less than 50% reduction in MADRS values or still meeting DSM-IV Criteria), Women who are not pregnant, breastfeeding, nor planning on becoming so during the study period; Additionally"
Is the utilization of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) sanctioned by the FDA?
"Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) is relatively untested, so it was given a safety score of 1 on our assessment scale. This phase 1 study has limited data demonstrating efficacy and safety."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- The University of Texas Health Science Center at Houston: < 24 hours
Average response time
- < 2 Days
Typically responds via
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