Cicatrix Clinical Trial
Official title:
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.
Nowadays, cesarean is one of the most common surgical interventions and its prevalence has
increased in most countries in the recent years. Delay in healing of cesarean wound and
formation of visible scar are common symptoms of maternal morbidity after cesarean section.
These complications affect mother's quality of life due to stress, anxiety, delay in mother's
ability and health recovery, and also they are associated with additional cost as a result of
the increased need for wide spectrum antibiotics and sometimes hospitalization and repeated
repair of wound. Improve the final aspect of would and visible scars, have been a challenge
for medicine. Mesenchymal stem cells (MSC) are a population of pluripotent stem cells that
are self-renewing and capable of differentiating into canonical cells of the mesenchyme.
Recently, stem cells have been applied to regenerative medicine, even for internal organs
such as blood vessels, nerves, and heart.
The study is to investigate the efficacy and safety of perinatal tissue mesenchyme stem cells
treatment on the appearance of a caesarean scar as compared to a similar untreated scar. This
is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the
efficacy and safety of perinatal tissue mesenchyme stem cells (MSC) treatment on the
appearance of a caesarean scar as compared to a similar untreated scar. A total of ninety
(90) participants will be randomized (1:1:1) to receive MSC or placebo. All of participants
will be undergoing delivery by lower segment caesarean section through a transverse abdominal
incision, and there will be no clear indication for a particular surgical technique or
material to be used. In low-dose MSC 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; In high-dose MSC 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; And in placebo group, participants
will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel
once a day for continuous six days. After randomization, baseline data, and transdermal
treatment, participants will be followed up at 1 month, 3 months and 6 months. For the
purpose of the endpoint analysis and safety evaluations, the investigators will utilize an
"intention-to-treat" study population.
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