Amniotic membrane-derived mesenchymal stromal cells for the treatment of steroid-resistant acute GVHD

Amniotic membrane-derived mesenchymal stromal cells for the treatment of steroid-resistant acute GVHD - Amnion MSC for GVHD

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015017

Enrollment

Registered

2014-09-08

Start date

2014-09-16

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

steroid resistant GVHD

Interventions

infusion of Amnion derived MSC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Steroid Resistant GVHD grade II or over Steroid Resistant GVHD grade I or over with high risk transplantation for GVHD e.g. GVHD in HLA Haploidentical Transplantation

Exclusion criteria

Exclusion criteria: 1 patients with Liver damage other than GVHD (Total bililubin >2.0mg/dl or AST and/or ALT>200U/L 2 patients with Serum creatinine >2mg/dl 3 patients with allergy to bovine or porcine products 4 patienst with relapsed at MSC infusion 5 patients with uncontrolled infection 6 blood O2 saturation <94% even 3L/min Oxygen supply 7 Patients attending physician has determined ineligible.

Design outcomes

Primary

Measure	Time frame
Safety of up to 52 weeks after	—

Secondary

Measure	Time frame
CR to be continued 4 weeks or more CR/PR at the time of 4weeks after the first dose	—

Countries

Japan

Contacts

Public ContactToshihiro Soma

Hyogo college of Medicine Hematology

somat@hyo-med.ac.jp+81-798-45-6886

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026