A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Safety - Number of participants with non-healing wounds
研究概览
简要总结
Burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. When the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. The damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. Because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, Integra®, to examine the potential wound healing benefits of these stem cells. This is an investigational treatment and a first in-human trial. The purpose of this study is to test the safety of using a patient's own stem cells combined with Integra®, which the investigators call Integra®-Stem Cells (Integra®-SC). The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This is a single-blind study where the participant will not know which area is covered with Integra®-SC.
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
- •Aged ≥ 18 years.
- •Total body surface area (TBSA) ≥ 5%.
- •Full-thickness burn requiring operative procedures.
- •Admitted ≤ 120 hours following burn.
- •Injury location includes a contralateral area.
排除标准
- •All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
- •Patients who are moribund.
- •Known infection with any of the following: Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Human T-lymphotropic Virus (HTLV), Syphilis, or West Nile Virus.
- •Injury location limited to face and/or hands.
- •Pregnancy.
- •Active cancer and currently undergoing treatment.
结局指标
主要结局
Safety - Number of participants with non-healing wounds
时间窗: Acute hospitalization (1-4 months post admission depending on severity of injury)
The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, non-healing wounds that require an additional (unplanned) operation will be recorded as an in-hospital complication.
Safety - Number of patients with poor scarring requiring additional (unplanned) operation
时间窗: Discharge to to 1 year post-discharge
The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, poor scarring requiring an additional (unplanned) operation will be recorded as a late-onset complication.
Safety - Number of participants with surgical site infections
时间窗: Acute hospitalization (1-4 months post admission depending on severity of injury)
The primary outcome of this study is safety. In order to assess the safety of Integra®-SC, surgical site infections that require an additional (unplanned) operation will be recorded as an in-hospital complication.
次要结局
- Scar Formation - Vascularity of the healed area(Discharge to 1 year post-discharge)
- Quality of skin regeneration - Signs of wound infection(Acute hospitalization (1-4 months post admission depending on severity of injury))
- Scar formation - Pliability of the healed area(Discharge to 1 year post-discharge)
- Time of wound healing(Acute hospitalization (1-4 months post admission depending on severity of injury))
- Quality of skin regeneration - Abnormal scar formation(Acute hospitalization (1-4 months post admission depending on severity of injury))
- Quality of skin regeneration - Arterial bleeding from the wound site(Acute hospitalization (1-4 months post admission depending on severity of injury))
- Quality of skin regeneration - Detachment of Integra®-SC(Acute hospitalization (1-4 months post admission depending on severity of injury))
- Scar formation - Pigmentation of the healed area(Discharge to 1 year post-discharge)
- Scar formation - Height of the healed area(Discharge to 1 year post-discharge)
研究者
Marc Jeschke
Vice President of Research, Medical Director Burn Unit
Hamilton Health Sciences Corporation