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

Maternal and Child Health Hospital of Foshan

Status and phase: Withdrawn; Phase 2

Conditions: Cicatrix

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04034615

MCHHFoshan-1902

Details and patient eligibility

About

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.

Full 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.

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: Triple Blind

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0 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