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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 : Recruiting
First Posted : July 26, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan

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.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 20, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Biological: Placebo
Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Erythema [ Time Frame: Three years post treatment ]
    measured by reflectance

  2. Pigmentation [ Time Frame: Three years post treatment ]
    measured by reflectance

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Zhengping Liu, MD + 86 757 82969772 liuzphlk81@outlook.com
Contact: Dazhi Fan, MD + 86 757 82969772 fandazhigw@163.com

Locations
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China, Guangdong
Maternal and Child Health Hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Zhengping Liu, MD    86 757 82969772    liuzphlk81@outlook.com   
Contact: Dazhi Fan, MD    86 757 82969772    fandazhigw@163.com   
Sponsors and Collaborators
Maternal and Child Health Hospital of Foshan
Investigators
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Principal Investigator: Zhengping Liu, MD Maternal and Child Health Hospital of Foshan
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Responsible Party: Zhengping Liu, MD, Director, Maternal and Child Health Hospital of Foshan
ClinicalTrials.gov Identifier: NCT04034615    
Other Study ID Numbers: MCHHFoshan-1902
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan:
Mesenchyme Stem Cells
Cesarean Section
Scars
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes