Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mesenchyme Stem Cells low-dose group; Mesenchyme Stem Cells high-dose group; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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.; 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.; Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mesenchyme Stem Cells; Cesarean Section; Scars