Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium

NCT03724617 | Completed DMC

• 1 other identifier: SRRSHRMC20180924
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.

Conditions

Thin Endometrium; Intrauterine Adhesion

Keywords

thin endometrium; Intrauterine Adhesion; stem cell; Collagen scaffold

Outcome Measures

Primary Outcomes (1)

• the change of endometrial thickness

  B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration.

  Change from Baseline endometrial thickness at 6 months

Secondary Outcomes (3)

• pregnancy rate

  pregnancy rate at 1 year

• live birth rate

  live birth rate at 1 year

• abortion rate

  abortion rate at 1 year

Study Arms (1)

stem cell therapy

EXPERIMENTAL

Drug: umbilical cord mesenchymal stem cells combined with collagen scaffold

Interventions

umbilical cord mesenchymal stem cells combined with collagen scaffold DRUG

3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded.

stem cell therapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.
• Women aged 20-40 years with fertility requirements
• Infertility patients who are treated in this hospital
• After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.
• or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
• HBVAg negative, HCV negative, HIV negative, syphilis negative
• Normal bone marrow morphology, normal blood routine
• Previously failed to receive relevant stem cell therapy

You may not qualify if:

• Those who cannot accept the treatment observation process required by the test
• There are contraindications for hysteroscopic surgery;
• congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation
• Patients with chromosomal abnormalities
• contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.
• Patients without fertility requirements

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw hopital,School of medicine,Zhejiang University

Hangzhou, China

Location

Related Publications (1)

• Zhang Y, Shi L, Lin X, Zhou F, Xin L, Xu W, Yu H, Li J, Pan M, Pan Y, Dai Y, Zhang Y, Shen J, Zhao L, Lu M, Zhang S. Unresponsive thin endometrium caused by Asherman syndrome treated with umbilical cord mesenchymal stem cells on collagen scaffolds: a pilot study. Stem Cell Res Ther. 2021 Jul 22;12(1):420. doi: 10.1186/s13287-021-02499-z.

  PMID: 34294152 DERIVED

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Xiaona Lin

  Sir Run Run Shaw Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior doctor

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: October 29, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: April 13, 2021

Record last verified: 2018-10

Locations

CN (1)