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Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars

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ClinicalTrials.gov Identifier: NCT03181087
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan

Brief Summary:
The purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.

Condition or disease Intervention/treatment Phase
Uterine Scar Other: Umbilical cord MSCs Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single-arm, Open Study of the Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
Estimated Study Start Date : November 11, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Umbilical cord MSCs Group
1*10^7 Umbilical cord Mesenchymal Stem Cells (MSCs)
Other: Umbilical cord MSCs
Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.



Primary Outcome Measures :
  1. Safety evaluation through vital signs, the results of clinical lab tests and adverse events [ Time Frame: 6 months post treatment ]
    Safety evaluation through vital signs, the results of clinical lab tests and adverse events.


Secondary Outcome Measures :
  1. Number of participants with uterine niche [ Time Frame: 6 months post treatment ]
    The niche is defined as a triangular anechoic area at the presumed site of incision in the uterus by transvaginal utrasonography.

  2. Change of uterine scar thickness [ Time Frame: 6 weeks, 3 and 6 months post treatment ]
    The scar thickness be measured using a transvaginal utrasonography

  3. Change of uterine scar area [ Time Frame: 6 weeks, 3 and 6 months post treatment ]
    The scar area will be measured using a transvaginal utrasonography

  4. Number of participants with endometritis [ Time Frame: 6 months post treatment ]
    Endometritis is defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38℃), abdominal pain, uterine tenderness, or purulent drainage from the uterus.

  5. Number of participants with wound infection [ Time Frame: 6 months post treatment ]
    Wound infection is defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis.

  6. Immunoglobulin concentrations in breast milk and serum [ Time Frame: 6 weeks, 3 and 6 months post treatment ]
    Breast milk and serum immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) are detected by transmission immune turbidity method using automatic biochemical analyzer.

  7. Adverse events occurrence [ Time Frame: 6 months post treatment ]
    Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.



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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 comply with study dosing and completed the entire course of the study
  • Willing to give and sign an informed consent form and a photographic release form

Exclusion Criteria:

  • Fibroids
  • Placenta previa
  • Placenta abruption
  • Multiple gestation
  • Antepartum hemorrhage
  • Preeclampsia/Eclampsia
  • Hepatic or renal dysfunction
  • Any systemic uncontrolled disease
  • Inability to provide consent

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): NCT03181087


Contacts
Contact: Zhengping Liu, MD + 86 757 82969772 liuzphlk81@outlook.com
Contact: Dazhi Fan, MD + 86 757 82969772 fdz1988@gmail.com

Locations
China, Guangdong
Maternal and Child Health Hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Deqin Jia, BD    + 86 757 82969772    trials_fs_mchh@sohu.com   
Sub-Investigator: Dazhi Fan, MD         
Sponsors and Collaborators
Maternal and Child Health Hospital of Foshan
Investigators
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
ClinicalTrials.gov Identifier: NCT03181087     History of Changes
Other Study ID Numbers: MCHHFoshan-1701
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Mesenchymal Stem Cells
Cesarean Section
Uterine Scar