NCT02772289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

May 10, 2016

Last Update Submit

May 6, 2019

Conditions

Cicatrix

Keywords

Mesenchyme Stem CellsCesarean SectionScars

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Wound healing status

    14 days post surgery

  • Erythema measured by reflectance

    1st, 3rd, 6th month post treatment

  • Pigmentation measured by reflectance

    1st, 3rd, 6th months post treatment

  • Scar Thickness and Uniformity

    1st, 3rd, 6th month post treatment

  • Change of scar area

    1st, 3rd, 6th month post treatment

  • +3 more secondary outcomes

Study Arms (3)

Mesenchymal Stem Cells low-dose group

EXPERIMENTAL

Target dose of 3 million Mesenchymal Stem Cells

Biological: Mesenchyme Stem Cells low-dose group

Mesenchymal Stem Cells high-dose group

EXPERIMENTAL

Target dose of 6 million Mesenchymal Stem Cells

Biological: Mesenchyme Stem Cells high-dose group

Placebo

PLACEBO COMPARATOR

Placebo without Mesenchyme Stem Cells

Biological: Placebo

Interventions

Mesenchyme Stem Cells low-dose groupBIOLOGICAL

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 low-dose group
Mesenchyme Stem Cells high-dose groupBIOLOGICAL

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.

Mesenchymal Stem Cells high-dose group
PlaceboBIOLOGICAL

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

Placebo

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

Related Publications (2)

  • 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.

    PMID: 32586366DERIVED

  • 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.

    PMID: 29499740DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Population Groups

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Zhengping Liu, MD

    Maternal and Child Health Hospital of Foshan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 13, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2018

Study Completion

March 1, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

CN(1)