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

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ClinicalTrials.gov Identifier: NCT02772289
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan

Tracking Information
First Submitted Date  ICMJE May 10, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
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 Measures  ICMJE
 (submitted: May 11, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cicatrix
Intervention  ICMJE
  • Biological: Mesenchyme Stem Cells low-dose 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.
  • Biological: Mesenchyme Stem Cells high-dose 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.
  • Biological: Placebo
    Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
Study Arms  ICMJE
  • Experimental: Mesenchymal Stem Cells low-dose group
    Target dose of 3 million Mesenchymal Stem Cells
    Intervention: Biological: Mesenchyme Stem Cells low-dose group
  • Experimental: Mesenchymal Stem Cells high-dose group
    Target dose of 6 million Mesenchymal Stem Cells
    Intervention: Biological: Mesenchyme Stem Cells high-dose group
  • Placebo Comparator: Placebo
    Placebo without Mesenchyme Stem Cells
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Smoking
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772289
Other Study ID Numbers  ICMJE MCHHFoshan-1602
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan
Study Sponsor  ICMJE Maternal and Child Health Hospital of Foshan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhengping Liu, MD Maternal and Child Health Hospital of Foshan
PRS Account Maternal and Child Health Hospital of Foshan
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP