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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cicatrix

Intervention / Treatment
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* Biological: Mesenchyme Stem Cells low-dose group
* Biological: Mesenchyme Stem Cells high-dose group
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal Stem Cells low-dose group<br>Target dose of 3 million Mesenchymal Stem Cells | Biological: Mesenchyme Stem Cells low-dose group<br>* 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.<br>|
| Experimental: Mesenchymal Stem Cells high-dose group<br>Target dose of 6 million Mesenchymal Stem Cells | Biological: Mesenchyme Stem Cells high-dose group<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo without Mesenchyme Stem Cells | Biological: Placebo<br>* Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Vancouver Scar Scale (VSS) | The investigators measured quartile grading scale at 1st, 3rd and 6th months of study and evaluated the change of the scale | 1st, 3rd, 6th month post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing status | 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. | 14 days post surgery | 
| Erythema measured by reflectance | measured by reflectance | 1st, 3rd, 6th month post treatment | 
| Pigmentation measured by reflectance | measured by reflectance | 1st, 3rd, 6th months post treatment | 
| Scar Thickness and Uniformity | 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. | 1st, 3rd, 6th month post treatment | 
| Change of scar area | 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. | 1st, 3rd, 6th month post treatment | 
| Immunoglobulin concentrations in breast milk | Breast milk immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) were detected by transmission immune turbidity method using automatic biochemical analyzer. | 1st, 3rd, 6th month post treatment | 
| Subject's satisfaction | Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good. | 6th month post treatment | 
| Adverse events occurrence | Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scars, Mesenchyme Stem Cells, Cesarean Section