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

M

Maternal and Child Health Hospital of Foshan

Status and phase

Completed
Phase 2

Conditions

Cicatrix

Treatments

Biological: Mesenchyme Stem Cells low-dose group
Biological: Mesenchyme Stem Cells high-dose group
Biological: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02772289
MCHHFoshan-1602

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

21 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups, including a placebo group

Mesenchymal Stem Cells low-dose group
Experimental group
Description:
Target dose of 3 million Mesenchymal Stem Cells
Treatment:
Biological: Mesenchyme Stem Cells low-dose group
Mesenchymal Stem Cells high-dose group
Experimental group
Description:
Target dose of 6 million Mesenchymal Stem Cells
Treatment:
Biological: Mesenchyme Stem Cells high-dose group
Placebo
Placebo Comparator group
Description:
Placebo without Mesenchyme Stem Cells
Treatment:
Biological: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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