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
Dazhi FanZhengping Liu

Abstract

Uterine niche 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. The main clinical manifestations are postmenstrual spotting and intrauterine infection, which may seriously affect the daily life of nonpregnant women. Trials have shown an excellent safety and efficacy for the potential of mesenchymal stem cells (MSCs) as a therapeutic option for scar reconstruction. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment for the uterine niche. This phase II clinical trial is a single-center, prospective, randomized, double-blind, placebo-controlled with 2 arms. One hundred twenty primiparous participants will be randomly (1:1 ratio) assigned to receive direct intramuscular injection of MSCs (a dose of 1*10 cells in 1 mL of 0.9% saline) (MSCs group) or an identical-appearing 1 mL of 0.9% saline (placebo-controlled group) near the uterine incision. The primary outcome of this trial is to evaluate the proportion of participants at 6 months who is found uterine niche in the uterus by transvaginal utrasonography. Adverse events will be documented in a case report form. The study will be conducted ...Continue Reading

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Citations

May 24, 2020·Journal of Assisted Reproduction and Genetics·Ariel BenorAlan DeCherney
Oct 15, 2020·Cells·Sahar EsfandyariAyman Al-Hendy
Jan 26, 2021·Reproductive Medicine and Biology·Ruttachuk RungsiwiwutKamthorn Pruksananonda
Dec 31, 2020·Genes·Paz de la Torre, Ana I Flores
Mar 3, 2021·Cell and Tissue Research·Neda KeyhanvarRalf Dittrich
May 17, 2021·European Journal of Obstetrics, Gynecology, and Reproductive Biology·Jiawen WuShiyuan Wei
Jul 3, 2021·Cells·Sarama SahaSham S Kakar
Dec 31, 2021·Endocrine Reviews·Eisa Tahmasbpour MarzouniElena Jane Tucker

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Methods Mentioned

BETA
cesarean section

Clinical Trials Mentioned

NCT02968459

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