UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT06245746
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo) — BIOLOGICAL
    UCMSC-Exo will be infused intravenously.

Study Details

The purpose of the study is to explore the safety and efficacy of UCMSC-Exo in consolidation chemotherapy-induced myelosuppression in patients with acute myeloid leukemia after achieving complete remission.

Key Dates

Start date
Feb 26, 2025
Status verified
Mar 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: UCMSC-Exo intervention
    UCMSC-Exo will be preset with 3 escalation dose levels in single time infusion.

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the day that UCMSC-Exo is infused to up to 28 days (short-term safety follow-up) and 1 year (long-term safety follow-up) ]

Central Contacts

Related Studies