The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
NCT ID: NCT04034615
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-05-20
2022-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mesenchymal Stem Cells low-dose group
Target dose of 3 million Mesenchymal Stem Cells
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.
Mesenchymal Stem Cells high-dose group
Target dose of 6 million Mesenchymal Stem Cells
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.
Placebo
Placebo without Mesenchyme Stem Cells
Placebo
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
Interventions
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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.
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.
Placebo
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
35 Years
FEMALE
Yes
Sponsors
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Maternal and Child Health Hospital of Foshan
OTHER
Responsible Party
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Zhengping Liu, MD
Director
Principal Investigators
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Zhengping Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Maternal and Child Health Hospital of Foshan
Locations
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Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, China
Countries
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Other Identifiers
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MCHHFoshan-1902
Identifier Type: -
Identifier Source: org_study_id
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