- Intractable rare disease caused by immune rejection after hematopoietic stem cell transplantation
- It usually occurs 4-6 months after allogeneic hematopoietic stem cell transplantation, and it is a disease with a high mortality rate after the onset.
- The most commonly invaded site is the skin (80%) or the body appears in various forms of autoimmune disease.
Main clinical features
- Skin: erythema, dryness, nodules, inflamed skin, etc.
- Toenails: onycholysis, etc.
- Mouth: dryness, gingivitis, dental caries, etc.
- Eyes: dryness, burning sensation, glare, decreased tear production, etc.
- Liver: liver dysfunction
- Lungs: cough, shortness of breath, bronchitis, etc.
- Genitals: dryness, uterine stenosis, atrophy during reproduction
- Serous: pleurisy, pericarditis
Primary endpoint : overall response rate at 12 weeks
(Overall Response Rate, ORR)
IndicationSteroid refractory or dependence
Chronic graft-versus-host disease
Number of patients84 people
Cohort 1: 42 subjects in the test group
Cohort 2: 42 subjects in the test group
Dosing regimen2 weeks intervals / 3 times
SCM - CGH : 1.0 X 106 cells/kg
Designmulticenter, placebo-controlled, double-blind