Epidermolysis Bullosa
Conditions
Interventions
JR-031 is subcutaneously administered at the dose of 0.5 million cells /250 micro L /site every two centimeters around cutaneous ulcers. The maximum number of injection sites is 40 and the maximum dos
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed as Epidermolysis Bullosa 2) Patients who have skin ulcers which last more than 12 months 3) Patients who is 6 years old or elder and younger than 70 years old
Exclusion criteria
Exclusion criteria: 1) Patients who received a therapy with mesenchymal stem cell derived from human bone marrow or TEMUCELL HS injection. 2) Patients who are suffering from serious mental diseases. 3) Patients who are suffering from cancer or who have histories of suffering from cancer within 5 years prior to enrollment. 4) Patients who are pregnant or probably pregnant. 5) Patients who do not agree to take effective contraceptive measures during the study period. 6) Patients who have entered other clinical trials within 6 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients number who show 50% or more improvement in the size of cutaneous ulcer after 48 week treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes from baseline in the size of cutaneous ulcer after 1,2,4,8,16,24,32,40,48 week treatment 2) Rate of patients number who show 50% or more improvement in the size of cutaneous ulcer after 1,2,4,8,16,24,32,40 week treatment | — |
Countries
Japan
Contacts
Public ContactKatsuto Tamai
Graduate School of Medicine, Osaka University Department of Stem Cell Therapy Science
Outcome results
None listed