A Phase II, Randomized, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Vancouver Scar Scale score
研究概览
简要总结
The study is to investigate the long-term efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.
详细描述
This trial is a continuation of the investigators' previous clinical trial (NCT02772289). In the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. Although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased.
Some studies have suggested that it usually took 18-24 months for a typical scar matures. In this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous women receiving cesarean delivery
- •Ages between 21-35 years
- •Gestation ages ≥ 37 weeks and < 42 weeks
- •Willing to give and sign an informed consent form and a photographic release form
- •Willing to comply with study dosing and complete the entire course of the study
排除标准
- •Any systemic uncontrolled disease
- •Recent or current cancer
- •History or presenting with a keloid formation
- •Wounds or local disease in treatment area
- •Planning any other cosmetic procedure to the study area during the study period
结局指标
主要结局
Vancouver Scar Scale score
时间窗: Three years post treatment
The investigators measured scar at three years post treatment using Vancouver Scar Scale (VSS). The VSS included vascularity (normal, pink, red, or purple), pigmentation (normal, hypopigmented, mixed, or hyperpigmented), height (flat, \< 2 mm, 2-5 mm, or \> 5 mm), and pliability (normal, supple, yielding, firm, ropes, or contracture). Each variable contained ranked subscales that could be summed to obtain a total score ranging from 0 to 14, with 0 representing normal skin and a higher score representing a more marked or abnormal scar. The Chinese version of the VSS has been shown to have good intraclass correlations and Cronbach's α measures. All scars will be assessed independently by two observers on the same day when the participants are lying in a supine position with the scar exposed in bright light. If the data varies, another researcher will be required to assess the scar at the same day and the results with the highest frequency will be recorded.
次要结局
- Pigmentation(Three years post treatment)
- Scar Thickness and Uniformity(Three years post treatment)
- Subject's satisfaction(Three years post treatment)
- Erythema(Three years post treatment)
研究者
Zhengping Liu, MD
Director
Maternal and Child Health Hospital of Foshan