A study on the safety and effectiveness of giving additional CD34-selected stem cells to patients who don’t recover normal blood cell production after a stem cell transplant

The safety and efficacy of CD34-selected stem cell boost in patients with poor graft function or mixed chimerism after allogeneic hematopoietic cell transplantation

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0010088

Enrollment

Registered

2024-12-27

Start date

2024-12-16

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : CD34-Selected Hematopoietic Stem Cell Infusion: Peripheral blood stem cells from the hematopoietic stem cell donor are collected, and CD34-positive cells are selectivel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with Graft Dysfunction or Mixed Chimerism Following Allogeneic Hematopoietic Stem Cell Transplantation 1) Poor Graft Function (PGF): - Meets at least two of the following criteria: ? Neutrophil count < 1,000/µL ? Hemoglobin level < 8 g/dL ? Platelet count < 20,000/µL - Persistent for = 2 weeks. - Complete donor chimerism (= 95%). - Underlying disease in remission. - Exclusion of cytopenia caused by infection or drug-related toxicity. 2) Mixed Chimerism (MC): - Donor chimerism in the range of 5–95%.

Exclusion criteria

Exclusion criteria: - Patients with **Grade 3 or higher acute GVHD** or **extensive chronic GVHD**. - Cytopenia associated with **infection** or **drug use**. - Confirmed **relapse of the underlying disease**.

Design outcomes

Primary

Measure	Time frame
acute GVHD;treatment response	—

Secondary

Measure	Time frame
Survival rate	—

Countries

Korea, Republic of

Contacts

Public ContactSung Han Kang

Asan Medical Center

drpotter@amc.seoul.kr+82-2-3010-1453

Outcome results