NCT06210919已完成1 期
A Phase 1, Single-Center, Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Single Dose of TRTP-101 in Adults With Atrophic Scars
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CellinCells
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants with Dose Limiting Toxicity
研究概览
简要总结
The purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of TRTP-101 in adults with atrophic scars.
详细描述
A phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of TRTP-101 to each of the four sites of atrophic scar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female aged greater than 19 years
- •Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose
排除标准
- •History of cell therapy
- •Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
- •Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
- •Positive for virus infection
- •Use of Anticoagulant therapy or NSAIDs
- •Thrombocytopenia or other coagulation disorder
- •History of keloid scars
- •Infectious disease or other dermatitis in the area of the atrophic scar
- •Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy
- •Use of systemic steroid medication
- •History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
- •Use of retinoid medications
研究组 & 干预措施
TRTP-101
Experimental
Micro-Block (MiB) manufactured from autologous Adipose-derived Mesenchymal Stem Cells
干预措施: TRTP-101 (Biological)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicity
时间窗: within 4 weeks
Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101
次要结局
- Mean percent change in atrophic scar volume(1, 4, 8 and 12 weeks)
研究者
研究点 (1)
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