The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04034615|
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : February 21, 2020
|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)|
|Estimated Enrollment :||90 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|
|Estimated Study Start Date :||October 20, 2020|
|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.
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
|Contact: Zhengping Liu, MD||+ 86 757 email@example.com|
|Contact: Dazhi Fan, MD||+ 86 757 firstname.lastname@example.org|
|Principal Investigator:||Zhengping Liu, MD||Maternal and Child Health Hospital of Foshan|