Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression

Conditions

• Treatment-resistant Bipolar Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) — BIOLOGICAL
  Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow
• Placebo — BIOLOGICAL
  Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)

Study Details

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).

Key Dates

Start date

Apr 20, 2022

Status verified

Jun 2025

Primary completion

Dec 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal
  Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow
• Placebo Comparator: Placebo
  Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)

Primary Outcome Measure

Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: baseline, week 8, week 26 ]

Central Contacts

• Dana Razouq
  (713) 486-2523
  [email protected]

Locations (1)

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