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

Cicatrix Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772289
• Other study ID #: MCHHFoshan-1602
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: March 2019

Study information

• Verified date: May 2019
• Source: Maternal and Child Health Hospital of Foshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix

Intervention

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.
• 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
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Erythema measured by reflectance	measured by reflectance	1st, 3rd, 6th month post treatment
Secondary	Pigmentation measured by reflectance	measured by reflectance	1st, 3rd, 6th months post treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events occurrence	Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.	6 months