JPRN-jRCTa060210018已完成1 期
A Phase 1 Safety Evaluation of Bone Marrow-Derived Mesenchymal Stem/Stromal Cells Therapy in Subjects with Refractory Cutaneous Ulcers - A Safety Study of BM-Derived MSC Thrapy in Refractory Cutaneous Ulcers
Ichinohe Tatsuo0 个研究点目标入组 2 人开始时间: 2021年6月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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