Clinical Trial: Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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 Summary:

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 transd
Sponsor: Maternal and Child Health Hospital of Foshan

Current Primary Outcome: 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


Original Primary Outcome: Change of Vancouver Scar Scale (VSS) [ Time Frame: 1st, 3rd, 6th month post treatment ]

We measured quartile grading scale at 1st, 3rd and 6th months of study and evaluated the change of the scale


Current Secondary Outcome:

  • Wound healing status [ Time Frame: 14 days post surgery ]
    Wound healing status was assessed using REEDA scale which is based on the amount of redness, edema, ecchymosis, discharge and the approximation of wound edges (each one scored between 0-3); the final score was the sum of the items scores. Lower score indicated better healing.
  • Erythema measured by reflectance [ Time Frame: 1st, 3rd, 6th month post treatment ]
    measured by reflectance
  • Pigmentation measured by reflectance [ Time Frame: 1st, 3rd, 6th months post treatment ]
    measured by reflectance
  • Scar Thickness and Uniformity [ Time Frame: 1st, 3rd, 6th month post treatment ]
    A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity.
  • Change of scar area [ Time Frame: 1st, 3rd, 6th month post treatment ]
    A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar area.
  • Immunoglobulin concentrations in breast milk [ Time Frame: 1st, 3rd, 6th month post treatment ]
    Breast milk immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) were detected by transmission immune turbidity method using automatic biochemical analyzer.
  • Subject's satisfaction [ Time Frame: 6th month post treatment ]
    Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
  • Adverse events occurrence [ Time Frame: 6 months ]
    Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.


Original Secondary Outcome: Same as current

Information By: Maternal and Child Health Hospital of Foshan

Dates:
Date Received: May 10, 2016
Date Started: May 2016
Date Completion: November 2018
Last Updated: May 12, 2016
Last Verified: May 2016