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

Phase 1

Conditions: Refractory Cutaneous Ulcers

Registration Number: JPRN-jRCTa060210018

Lead Sponsor: Ichinohe Tatsuo

Brief Summary: The results of two cases showed that intravenous administration of TEMCEL HS injection for patients with intractable skin ulcers was able to control and reduce ulcers, and skin reconstruction was performed. We believe this led to a favorable outcome later on. However, the efficacy of topical skin administration of Temcel HS injection was not clear. In addition, in terms of pain evaluation, intravenous administration of TEMCEL HS injection is considered to be an effective treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 2

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events (presence/absence, severity, time points of the occurrence)

Secondary Outcome Measures

Name	Time	Method
Descriptive accumulation of the following data in each study subject:<br>#1 Evaluation of status of cutaneous ulcers<br>#2 Changes of skin pain evaluated by Numerical Rating Scale (NRS)<br>#3 Vital signs, blood tests, and urine tests