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

NCT ID: NCT02772289

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-03-31

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.

Conditions

Cicatrix

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mesenchymal Stem Cells low-dose group

Target dose of 3 million Mesenchymal Stem Cells

Group Type: EXPERIMENTAL

Mesenchyme Stem Cells low-dose group

Intervention Type: BIOLOGICAL

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.

Mesenchymal Stem Cells high-dose group

Target dose of 6 million Mesenchymal Stem Cells

Group Type: EXPERIMENTAL

Mesenchyme Stem Cells high-dose group

Intervention Type: BIOLOGICAL

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

Placebo without Mesenchyme Stem Cells

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maternal and Child Health Hospital of Foshan

OTHER

Sponsor Role: lead

Responsible Party

Zhengping Liu, MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhengping Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Maternal and Child Health Hospital of Foshan

Locations

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, China

Countries

China

References

Fan D, Zeng M, Xia Q, Wu S, Ye S, Rao J, Lin D, Zhang H, Ma H, Han Z, Guo X, Liu Z. Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial. Stem Cell Res Ther. 2020 Jun 25;11(1):244. doi: 10.1186/s13287-020-01695-7.

Reference Type: DERIVED

PMID: 32586366 (View on PubMed)

Fan D, Xia Q, Wu S, Ye S, Liu L, Wang W, Guo X, Liu Z. Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial. Trials. 2018 Mar 2;19(1):155. doi: 10.1186/s13063-018-2478-x.

Reference Type: DERIVED

PMID: 29499740 (View on PubMed)

Other Identifiers

MCHHFoshan-1602

Identifier Type: -

Identifier Source: org_study_id