A Safety Study of Bone Marrow-Derived Mesenchymal Stem/Stromal Cells Therapy in Refractory Skin Ulcers

JRCT ID: jRCTa060210018

Registered date:23/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Refractory Cutaneous Ulcers
• Date of first enrollment: 23/06/2021
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravenous and subcutaneous administration of allogeneic bone marrow-derived mesenchymal stromal/stem cells

Outcome(s)

• Primary Outcome: Adverse events (presence/absence, severity, time points of the occurrence)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ichinohe Tatsuo
• Secondary Sponsor: Hiroshima University