Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
NCT ID: NCT02968459
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2021-10-31
2022-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Uterine niche, also named cesarean scar defect, deficient cesarean scar, pouch, or diverticulum, is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. It is one of the most common complications associated with previous cesarean section. The primary clinical manifestation is postmenstrual spotting, which may seriously affect the daily life of patients. The treatment includes medical treatment, such as oral contraceptives, and surgical methods, such as hysteroscopy resectoscopic correction, endometrial ablation, laparoscopic surgery, and transvaginal repair surgery. Although good outcomes are reported in each study, present treatments could not decrease the incidence among women after undergoing cesarean section.
Mesenchymal stem cells (MSCs) are long-lived cells with the ability of both self-renewal and differentiation into multi-potential cells, such as osteoblasts, adipocytes and smooth muscle cells. Trials with MSCs in patients after myocardial infarction have shown an excellent safety and efficacy. In this trial, the investigators postulate that MSCs can reduce uterine niche and convert scar tissue to viable myometrium. To test the hypothesis, the investigators therefore undertake a Phase II clinical trial of the treatment for uterine niche among primiparous women who undergo cesarean section.
This is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of umbilical cord mesenchymal stem cells treatment on the caesarean section uterine scars. A total of one hundred and twenty (120) participants will be randomized (1:1) to receive direct local intramuscular injection of 1\*10\^7 MSCs (a dose of 1\*10\^7 cells in 1 ml of 0.9% saline) (MSCs group) or an identical-appearing 1ml of 0.9% saline placebo (placebo-controlled group). Cesarean procedures and care will follow usual practices. All participants will be performed by obstetricians from the investigators' department using a unified double-layer uterine closure technique with a continuous absorbable polyglycolic 1-0 suture. After suturing the uterine incision, direct local intramuscular injection will be performed in the uterine incision as soon as possible on the operating table. One ml solution will be injected as twenty aliquots of 0.05ml into each injection site on the incision. Injection sites will be selected near the incision at evenly 20 different sites. Participants will be followed up at 6 weeks, 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Umbilical cord MSCs Group
1\*10\^7 Umbilical cord MSCs
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.
Placebo-Controlled Group
1ml of 0.9% saline
0.9% Saline
Participants will receive direct local intramuscular injection 1ml of 0.9% saline in the uterine incision.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
0.9% Saline
Participants will receive direct local intramuscular injection 1ml of 0.9% saline in the uterine incision.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Placenta previa
* Placenta abruption
* Multiple gestation
* Antepartum hemorrhage
* Preeclampsia/Eclampsia
* Hepatic or renal dysfunction
* Any systemic uncontrolled disease
* Inability to provide consent
21 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maternal and Child Health Hospital of Foshan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhengping Liu, MD
Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhengping Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Maternal and Child Health Hospital of Foshan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fan D, Wu S, Ye S, Wang W, Guo X, Liu Z. Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche: Protocol for a prospective, randomized, double-blinded, placebo-controlled clinical trial. Medicine (Baltimore). 2017 Nov;96(44):e8480. doi: 10.1097/MD.0000000000008480.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCHHFoshan-1603
Identifier Type: -
Identifier Source: org_study_id