A Single-center, Single Group, Dose Escalation, Phase 1 Clinical Trial to Investigate the Safety of TPX-121 in Subjects With Moderate-to-Extreme Nasolabial Folds
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
Nasolabial folds augmentation is possible through dermal filler and botulinum toxin, however, safety issues are existed as well as efficacy. Therefore, there is a need for a safer procedure for nasolabial folds correction. This study (Project No. TPX-121) assesses the safety of allogeneic fibroblasts (TPX-115) on nasolabial folds. The safety endpoint is dose-limiting toxicity (DLT). In addition, exploratory endpoints are the improvement of nasolabial folds in Wrinkle Severity Rating Scale (WSRS) at week 4 and 12, change in WSRS and Wrinkle Severity Scale (WSS) at week 4 and 12, and overall appearance improvement rate in Global Aesthetic Improvement Scale (GAIS) at week 4 and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Be 19 years old or older
- •Have confirmed nasolabial folds severity equal to or more than grade 3 evaluated by WSRS and WSS at face to face evaluation.
- •Have unsatisfied or very unsatisfied nasolabial folds.
- •Voluntarily sign the informed consent for participation in the study.
排除标准
- •Current disease and medical history
- •Inflammatory and infectious skin diseases, unhealed wounds and scars (e.g. Keloids), or benign tumor on nasolabial folds.
- •Chronic skin diseases (e.g. Psoriasis, Atopic dermatitis).
- •Genetic diseases that affect fibroblasts or collagen (e.g. Achondroplasia, Osteogenesis imperfecta).
- •Autoimmune diseases.
- •Active hepatitis B or C (However, in the case of simple carriers or hepatitis B, except when the antiviral agent was stably taken for 6 months prior to screening).
- •Human immunodeficiency virus (HIV) positive.
- •Coagulopathy.
- •History of malignant tumors within the last 5 years.
- •Anaphylaxis or severe combined allergy
- •Have allergies to bovine proteins or gentamicin.
- •Acute or chronic infectious diseases.
- •Severe heart diseases (e.g. Myocardial infarction, Heart failure), severe liver diseases (e.g. Cirrhosis, Liver failure), or severe renal diseases (e.g. Kidney failure).
- •Hypersensitivity to amide-based local anesthetics (However, those who agree not to use local anesthetics can register).
- •Prohibited drugs and treatments.
- •Administered systemic corticosteroids within 12 weeks prior to screening or is scheduled to be administered for at least 2 weeks during the study.
- •Treated cell therapy or stem cell therapy within 1 year prior to screening.
- •Surgical procedures or surgeries such as fillers or fat grafting on facial part within 1 year prior to screening.
- •Surgical procedures or surgeries of permanent fillers on facial part prior to screening.
- •Surgical procedures or surgeries of botulinum toxin injection or face lift surgery on facial part within 6 months prior to screening.
- •Planned facial cosmetic surgery to improve nasolabial folds during the study.
- •Laboratory inspection
- •Those who fall under the following figures during screening. 1) White blood cell < 4.5x10^3/ul and > 11.0x10^3/ul 2) Platelet count < 100,000/mm^3 3) Hemoglobin < 9g/dL
- •Disagree to take pictures of nasolabial folds
- •Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptice.
- •Have participated in other clinical trials and recevied investigational products/devices within 30 days of this study.
- •Be deemed inadequate for the study by investigators(e.g. A person with severe asymmetry in the lower echocardiogram).
研究组 & 干预措施
low dose
干预措施: TPX-115(allogeneic fibroblasts) (Biological)
middle dose
干预措施: TPX-115(allogeneic fibroblasts) (Biological)
high dose
干预措施: TPX-115(allogeneic fibroblasts) (Biological)
结局指标
主要结局
Dose-limiting toxicity
时间窗: Week 4
The number of subjects evaluated grade 3 or higher adverse drug reactions according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
次要结局
未报告次要终点