Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03522545 · ClinicalTrials.gov registry record · Phase 1
Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
A Phase 1 study of Treatment-resistant Bipolar Depression, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03522545: Recruiting Phase 1 study of Treatment-resistant Bipolar Depression, sponsored by The University of Texas Health Science Center, Houston.
NCT03522545 is a Phase 1 study of Treatment-resistant Bipolar Depression that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03522545, a Phase 1 study of Treatment-resistant Bipolar Depression, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
What NCT03522545 shows while recruiting
NCT03522545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Treatment-resistant Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03522545 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03522545 about?
NCT03522545 is a clinical study titled "Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression". 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).
What is the current status of trial NCT03522545?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-04-20. Estimated completion is 2026-12-01.
What conditions does trial NCT03522545 study?
This clinical trial studies the following conditions: Treatment-resistant Bipolar Depression.
What interventions are being tested in trial NCT03522545?
The interventions under investigation include: Placebo (BIOLOGICAL), Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03522545?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03522545 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Treatment-resistant Bipolar Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03522545's enrollment target sits among peer trials
30 1333rd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI