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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cicatrix Biological: Mesenchyme Stem Cells low-dose group Biological: Mesenchyme Stem Cells high-dose group Biological: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal Stem Cells low-dose group
Target dose of 3 million Mesenchymal Stem Cells
 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.
Experimental: Mesenchymal Stem Cells high-dose group
Target dose of 6 million Mesenchymal Stem Cells
 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.
Placebo Comparator: Placebo
Placebo without Mesenchyme Stem Cells
 Biological: Placebo
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Erythema measured by reflectance [ Time Frame: 1st, 3rd, 6th month post treatment ]
    measured by reflectance

  3. Pigmentation measured by reflectance [ Time Frame: 1st, 3rd, 6th months post treatment ]
    measured by reflectance

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • Smoking
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772289


Locations
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China, Guangdong
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, China, 528000
Sponsors and Collaborators
Maternal and Child Health Hospital of Foshan
Investigators
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Principal Investigator: Zhengping Liu, MD Maternal and Child Health Hospital of Foshan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhengping Liu, MD, Director, Maternal and Child Health Hospital of Foshan
ClinicalTrials.gov Identifier: NCT02772289    
Other Study ID Numbers: MCHHFoshan-1602
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan:
Mesenchyme Stem Cells
Cesarean Section
Scars
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes