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Multipotent Mesenchymal Stromal Cells

Stem Cell Therapy for Bipolar Depression

Phase 1
Recruiting
Led By Jair C Soares, MD, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 18-65 years
Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above
Timeline
Screening 2 days
Treatment Varies
Follow Up 26 weeks
Awards & highlights

Study Summary

This trial is testing whether a cell therapy can help people with treatment-resistant bipolar depression.

Who is the study for?
This trial is for adults aged 18-65 with treatment-resistant bipolar depression, confirmed by specific interviews and hospital records. Participants must have a CRP level over 5 mg/L, not be pregnant or breastfeeding, use contraception if applicable, and be fluent in English for testing purposes. They should have had less than a 50% reduction in depression symptoms after previous treatments.Check my eligibility
What is being tested?
The study tests the effectiveness of Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (MSCs) against a placebo in treating bipolar depression that hasn't improved with standard treatments. The MSCs are derived from bone marrow to see if they can help alleviate depressive symptoms.See study design
What are the potential side effects?
While the side effects of MSC therapy are not detailed here, common concerns may include reactions at the infusion site, potential immune responses, or infection risks due to stem cell administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with a severe depressive episode.
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My depression hasn't improved much with treatment.
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I have been diagnosed with Bipolar I or II disorder.
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I am between 18 and 65 years old.
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I have been diagnosed with a severe depressive episode.
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I haven't improved after two treatments with specific mood stabilizers or antidepressants.
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I have tried a mood stabilizer or antidepressant for at least 6 weeks without success.
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My depression hasn't improved much with treatment.

Timeline

Screening ~ 2 days
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 2 days for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary outcome measures
Change in C-reactive protein (CRP) level as assessed by enzyme-linked immunosorbent assay (ELISA)
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of depression subscale
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of mania subscale
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Allogeneic Bone Marrow Derived Multipotent Mesenchymal StromalExperimental Treatment1 Intervention
Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow
Group II: PlaceboPlacebo Group1 Intervention
Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,874 Total Patients Enrolled
Jair C Soares, MD, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) (Multipotent Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT03522545 — Phase 1
Bipolar Depression Research Study Groups: Placebo, Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal
Bipolar Depression Clinical Trial 2023: Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) Highlights & Side Effects. Trial Name: NCT03522545 — Phase 1
Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) (Multipotent Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03522545 — Phase 1
Bipolar Depression Patient Testimony for trial: Trial Name: NCT03522545 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

I am bipolar and I can’t seem to find medication to help me 100%. Hoping this trial leads to a cure. And possibly helping me with my bipolar disease.
PatientReceived no prior treatments
I've tried other treatments and nothing is working for me, I'm at the end of my rope.
PatientReceived 2+ prior treatments
I have tried several different medications over the years and just cannot find one to really help me.
PatientReceived no prior treatments
I am so exhausted of trying to be happy. I have tried EVERYTHING! I have tried every old and new medication and all kinds of therapy. I want to have a reason to live. No matter how hard I try to no be depressed, I can get out of bed. No, I am not suicidal, we’re going to harm myself in anyway, either. But, this is not the life I signed up for him. I just want some help and willing to try anything.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

when can I start?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. The University of Texas Health Science Center at Houston: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~2 spots leftby Jul 2024