NCT06730022Available不适用
Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
Merakris Therapeutics1 个研究点 分布在 1 个国家开始时间: 2024年12月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.
详细描述
The primary purpose is to provide expanded access of Dermacyte Liquid to subjects who have serious cutaneous ulcers and wounds (e.g., ulcers related to diabetes mellitus, venous insufficiency, complications of systemic sclerosis or rheumatic disease; decubitus ulcers, burns, acute trauma, wound dehiscence, ischemic ulcers, and mixed etiology ulcers). Eligible subjects must have a high likelihood of significant morbidity, loss of quality of life, potential amputation, or mortality without efficacious treatment. As there are many types of patients who may be enrolled, study results will not have statistical significance.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years of age or older
- •Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator
排除标准
- •Must not be pregnant or lactating
- •Must not have known malignancies
- •Must not be less than 18 years of age
研究者
研究点 (1)
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相关资讯
Merakris Therapeutics Reports Positive Interim Data for MTX-001 in Venous Leg Ulcers, Advances Toward Late-Stage Development- Merakris Therapeutics reported statistically significant ulcer size reduction with MTX-001 in chronic venous leg ulcers at Week 8 and Week 12 in an interim subgroup analysis.
- The company submitted cumulative safety and efficacy data from 95 treated subjects to the FDA, including results from Phase II study and expanded access program.
- FDA alignment on manufacturing scale-up and production of registrational drug batches positions MTX-001 for potential late-stage development by 2027.
- MTX-001 is a first-in-class injectable biologic derived from cell-free amniotic fluid, currently in Phase II trials for venous leg ulcers.5 months agoMerakris Therapeutics Achieves FDA Alignment on MTX-001 Development Pathway for Chronic Venous Leg Ulcers- Merakris Therapeutics completed a successful Type C meeting with the FDA, achieving regulatory alignment on clinical efficacy expectations, potency assay validation, and manufacturing scale-up plans for MTX-001.
- The FDA provided constructive feedback on the company's Biologic License Application strategy, establishing a clear and feasible clinical development pathway for the first-in-class injectable biologic.
- MTX-001, purified from cell-free amniotic fluid, is currently in Phase 2 trials for venous leg ulcers, addressing a significant unmet need with no FDA-approved drugs specifically indicated for non-healing venous leg ulcers.
- The regulatory alignment strengthens MTX-001's investment profile and positions the company for late-stage development and potential partnering opportunities.9 months agoMerakris Therapeutics Secures FDA Type C Meeting to Advance MTX-001 Wound Healing Therapy- Merakris Therapeutics has secured a Type C meeting with the FDA scheduled for November 21, 2025, to discuss clinical development and manufacturing scale-up plans for MTX-001, a first-in-class injectable biologic for chronic wounds.
- The meeting will focus on chemistry, manufacturing, and controls expectations, manufacturing scale-up requirements, and the ongoing Phase 2 double-blind, placebo-controlled study for venous leg ulcers treatment.
- MTX-001 is purified from cell-free amniotic fluid and demonstrated favorable safety and early efficacy signals in Part 1 of its Phase 2 trial, with results published in the International Wound Journal in March 2025.
- The regulatory milestone represents a critical step toward completing Phase 2 trials and initiating Phase 3 studies for this regenerative medicine therapy targeting patients with chronic, non-healing wounds.11 months ago