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

M

Maternal and Child Health Hospital of Foshan

Status and phase

Withdrawn
Phase 1

Conditions

Uterine Scar

Treatments

Other: Umbilical cord MSCs

Study type

Interventional

Funder types

Other

Identifiers

NCT03181087
MCHHFoshan-1701

Details and patient eligibility

About

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.

Sex

Female

Ages

21 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Umbilical cord MSCs Group
Experimental group
Description:
1\*10\^7 Umbilical cord Mesenchymal Stem Cells (MSCs)
Treatment:
Other: Umbilical cord MSCs

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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