Refractory Cutaneous Ulcers
Conditions
Interventions
Intravenous and subcutaneous administration of allogeneic bone marrow-derived mesenchymal stromal/stem cells
Sponsors
Ichinohe Tatsuo
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential subject must satisfy all of the folllowing criteria to be enrolled in the study: 1. Being at least 20 years of age at the time of participation in the study. 2. Suffering from a life-threatening cutaneous ulcer expected to be refractory to conventional treatment as demonstrated by severely impaired granulation tissue formation and/or decreased/ceased blood flow. 3. Given a signed Informed Consent Form by the subject indicating that the subject or his/her representative understands the study purpose and required procedures and is willing to participate in the study.
Exclusion criteria
Exclusion criteria: Any potential subject will be excluded from participating in the study when he/she meets any of the following criteria: 1. History of severe allergy (including drug hypersensitivity and allergic reactions to substances in the provided cellular products) 2. Coexistence of uncontrolled sytemic infection 3. Having a psychiatric symptoms or diorders that prevent him/her from participating in the study. 4. Concurrent presence or a history of malignant neoplasm within 5 years before the date of participation in the study. 5. Known or suspected to be pregnant. 6. Presumbaly irreversible multiorgan failure as a consequence of underlying skin disorders or comorbidities. 7. History of the participation of any other clinical trials within 6 months before the expected participation date. 8. Any conditions considered inappropriate for participation in this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (presence/absence, severity, time points of the occurrence) | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive accumulation of the following data in each study subject: #1 Evaluation of status of cutaneous ulcers #2 Changes of skin pain evaluated by Numerical Rating Scale (NRS) #3 Vital signs, blood tests, and urine tests | — |
Countries
Japan
Contacts
Public ContactTaizo Hirata
Hiroshima University
Outcome results
None listed