The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
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|ClinicalTrials.gov Identifier: NCT04034615|
Recruitment Status : Withdrawn (The pandemic resulted in no enrollments。)
First Posted : July 26, 2019
Last Update Posted : December 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cicatrix||Biological: Mesenchyme Stem Cells low-dose group Biological: Mesenchyme Stem Cells high-dose group Biological: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||May 20, 2021|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Mesenchymal Stem Cells low-dose group
Target dose of 3 million Mesenchymal Stem Cells
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.
Experimental: Mesenchymal Stem Cells high-dose group
Target dose of 6 million Mesenchymal Stem Cells
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.
Placebo Comparator: Placebo
Placebo without Mesenchyme Stem Cells
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
- Vancouver Scar Scale score [ Time Frame: Three years post treatment ]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.
- Erythema [ Time Frame: Three years post treatment ]measured by reflectance
- Pigmentation [ Time Frame: Three years post treatment ]measured by reflectance
- Scar Thickness and Uniformity [ Time Frame: Three years post treatment ]A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity.
- Subject's satisfaction [ Time Frame: Three years post treatment ]Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
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|Ages Eligible for Study:||21 Years to 35 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034615
|Maternal and Child Health Hospital of Foshan|
|Foshan, Guangdong, China, 528000|
|Principal Investigator:||Zhengping Liu, MD||Maternal and Child Health Hospital of Foshan|
|Responsible Party:||Zhengping Liu, MD, Director, Maternal and Child Health Hospital of Foshan|
|Other Study ID Numbers:||
|First Posted:||July 26, 2019 Key Record Dates|
|Last Update Posted:||December 21, 2022|
|Last Verified:||December 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Mesenchyme Stem Cells