Study Stopped
The pandemic resulted in no enrollments。
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
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedDecember 21, 2022
December 1, 2022
7 months
July 24, 2019
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vancouver Scar Scale score
The investigators measured scar at three years post treatment using Vancouver Scar Scale (VSS). The VSS included vascularity (normal, pink, red, or purple), pigmentation (normal, hypopigmented, mixed, or hyperpigmented), height (flat, \< 2 mm, 2-5 mm, or \> 5 mm), and pliability (normal, supple, yielding, firm, ropes, or contracture). Each variable contained ranked subscales that could be summed to obtain a total score ranging from 0 to 14, with 0 representing normal skin and a higher score representing a more marked or abnormal scar. The Chinese version of the VSS has been shown to have good intraclass correlations and Cronbach's α measures. All scars will be assessed independently by two observers on the same day when the participants are lying in a supine position with the scar exposed in bright light. If the data varies, another researcher will be required to assess the scar at the same day and the results with the highest frequency will be recorded.
Three years post treatment
Secondary Outcomes (4)
Erythema
Three years post treatment
Pigmentation
Three years post treatment
Scar Thickness and Uniformity
Three years post treatment
Subject's satisfaction
Three years post treatment
Study Arms (3)
Mesenchymal Stem Cells low-dose group
EXPERIMENTALTarget dose of 3 million Mesenchymal Stem Cells
Mesenchymal Stem Cells high-dose group
EXPERIMENTALTarget dose of 6 million Mesenchymal Stem Cells
Placebo
PLACEBO COMPARATORPlacebo without Mesenchyme Stem Cells
Interventions
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.
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.
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhengping Liu, MD
Maternal and Child Health Hospital of Foshan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 26, 2019
Study Start
May 20, 2021
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
December 21, 2022
Record last verified: 2022-12