NCT04034615

The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

A Phase II, Randomized, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Maternal and Child Health Hospital of Foshan · Academic / Other
• Sex: Female
• Age: 21 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The study is to investigate the long-term efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.

Detailed description

This trial is a continuation of the investigators' previous clinical trial (NCT02772289). In the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. Although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased. Some studies have suggested that it usually took 18-24 months for a typical scar matures. In this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.

Conditions

• Cicatrix

Interventions

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

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2019-07-26
• Last updated: 2022-12-21

Locations

1 site across 1 country: China