VALIDATION OF A GMP-COMPLIANT BIOPRINTING PROCESS FOR MANUFACTURING A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- bioprinted dermo epidermal substitute sterility assessment
研究概览
简要总结
Innovative technologies in the emerging field of regenerative medicine might allow an improvement in the treatment of deep complex wounds leading to faster and better wound healing. Among them, the bioprinting technology, consisting in "printing human cells and biomaterials" to create a "dermo-epidermal substitute" that mimics an alternative of the physiological skin is the most promising alternative.
Besides improving skin substitutes properties, bioprinting allows to translate the manufacturing process of tissue-engineered products from manual, operator-dependent processes to a reproducible and automated solution. This paves the way to the manufacturing of therapeutic bioprinted products at the point of care, as close as possible from patients.
详细描述
In this preclinical in vitro study, the investigators plan to generate GMP-compliant validation batches of "bio-printed dermo-epidermal substitutes" from 25 healthy volunteer patients' unused surgical tissue removed during plastic surgeries.
Volunteer's harvested tissue will allow to extract and then amplify the epidermal keratinocytes and dermal fibroblasts. Successive cultures and bioprinting steps will generate a "bio-printed dermo-epidermal substitute" in 2 or 3 weeks. A blood test may also be performed on the volunteers to characterize the genetic stability during the different stages of the process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult adult males or females
- •Members of a social security scheme.
- •No contraindications to general anesthesia
- •Relevant to a plastic or repair surgery indication generating surgical waste.
排除标准
- •Pregnant and/or nursing women
- •Persons deprived of liberty
- •Major under guardianship
- •Persons unable to read the backgrounder.
研究组 & 干预措施
a plastic or repair surgery indication generating surgical waste
干预措施: BLOOD SAMPLES (Biological)
a plastic or repair surgery indication generating surgical waste
干预措施: surgical tissue samples (Biological)
结局指标
主要结局
bioprinted dermo epidermal substitute sterility assessment
时间窗: 24 MONTHS
Culture media from dermo-epidermal bioprinted substitutes were sampled in Bactec culture bottles (Peds Plus Aerobic/F and Plus Anaerobic/F culture vials, containing each 40 mL of medium). The Bactec method (Becton Dickinson, Sparks, MD, USA) uses a computer-controlled incubation/detection system. The media used contained proprietary factors designed to inactivate a wide variety of antibacterial and antifungal agents. Bactec culture bottles were incubated at 37 °C for a total of 10 days, and automated readings were taken every 10 min. Detection of organisms resulted in an audible alarm and automatic recording of time to detection.
Population Doubling Rate of keratinocytes
时间窗: 24 MONTHS
Population Doubling Rate of fibroblasts
时间窗: 24MONTHS
次要结局
未报告次要终点