A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cicatrix
- Sponsor
- Maternal and Child Health Hospital of Foshan
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change of Vancouver Scar Scale (VSS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.
Detailed Description
Nowadays, cesarean is one of the most common surgical interventions and its prevalence has increased in most countries in the recent years. Delay in healing of cesarean wound and formation of visible scar are common symptoms of maternal morbidity after cesarean section. These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery, and also they are associated with additional cost as a result of the increased need for wide spectrum antibiotics and sometimes hospitalization and repeated repair of wound. Improve the final aspect of would and visible scars, have been a challenge for medicine. Mesenchymal stem cells (MSC) are a population of pluripotent stem cells that are self-renewing and capable of differentiating into canonical cells of the mesenchyme. Recently, stem cells have been applied to regenerative medicine, even for internal organs such as blood vessels, nerves, and heart. The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar. This is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells (MSC) treatment on the appearance of a caesarean scar as compared to a similar untreated scar. A total of ninety (90) participants will be randomized (1:1:1) to receive MSC or placebo. All of participants will be undergoing delivery by lower segment caesarean section through a transverse abdominal incision, and there will be no clear indication for a particular surgical technique or material to be used. In low-dose MSC group, participants will receive transdermal one dose of 1\*10\^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days; In high-dose MSC group, participants will receive transdermal one dose of 1\*10\^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days; And in placebo group, participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days. After randomization, baseline data, and transdermal treatment, participants will be followed up at 1 month, 3 months and 6 months. For the purpose of the endpoint analysis and safety evaluations, the investigators will utilize an "intention-to-treat" study population.
Investigators
Zhengping Liu, MD
Director
Maternal and Child Health Hospital of Foshan
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change of Vancouver Scar Scale (VSS)
Time Frame: 1st, 3rd, 6th month post treatment
The investigators measured quartile grading scale at 1st, 3rd and 6th months of study and evaluated the change of the scale
Secondary Outcomes
- Wound healing status(14 days post surgery)
- Erythema measured by reflectance(1st, 3rd, 6th month post treatment)
- Change of scar area(1st, 3rd, 6th month post treatment)
- Scar Thickness and Uniformity(1st, 3rd, 6th month post treatment)
- Pigmentation measured by reflectance(1st, 3rd, 6th months post treatment)
- Subject's satisfaction(6th month post treatment)
- Immunoglobulin concentrations in breast milk(1st, 3rd, 6th month post treatment)
- Adverse events occurrence(6 months)