Investigator initiated trial to evaluate the safety and efficacy of umbilical cord blood-derived mesenchymal stem cells for treatment of pediatric patients with steroid-refractory acute or chronic graft versus host disease.

Umbilical cord blood-derived mesenchymal stem cells for the treatment of steroid-refractory acute or chronic graft-versus-host-disease

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000389

Enrollment

Registered

2012-03-27

Start date

2012-01-05

Completion date

Unknown

Last updated

2019-03-11

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 : Allogeneic-Unrelated, Umbilical Cord Blood-Derived Mesenchymal stem cells( PROMOSTEM ®). 1st MSC infusion(1x10^6cells/kg)IV, 2nd MSC infusion(2x10^6cells/kg)IV and 3rd MSC infusio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Steroid-refractory acute or chronic graft-versus-host-disease 2. Acquisition of consent form 3. 0-30 years of age

Exclusion criteria

Exclusion criteria: 1. Withdrawal from the study 2. Progression of underlying hematologic diseases 3. Severe adverse effects related to the investigational drug

Design outcomes

Primary

Measure	Time frame
Safety(Vital sign, Physical examination, ECOG performance status/Adverse effects related to infusion);Treatment response of GVHD	—

Secondary

Measure	Time frame
Pediatric Quality of Life inventory	—

Countries

Korea, Republic of

Contacts

Public ContactMeong Hi Son

Samsung Medical Center

Outcome results