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

Intrauterine Adhesion Clinical Trial

Official title:

Clinical Study of Stem Cells in the Treatment of Thin Endometrium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724617
• Other study ID #: SRRSHRMC20180924
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2018
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.

2. Women aged 20-40 years with fertility requirements

3. Infertility patients who are treated in this hospital

4. 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.

5. 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.

6. HBVAg negative, HCV negative, HIV negative, syphilis negative

7. Normal bone marrow morphology, normal blood routine

8. Previously failed to receive relevant stem cell therapy

Exclusion Criteria:

1. Those who cannot accept the treatment observation process required by the test

2. There are contraindications for hysteroscopic surgery;

3. 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

4. Patients with chromosomal abnormalities

5. contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.

6. Patients without fertility requirements

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Thin Endometrium
• Tissue Adhesions

Intervention

Drug:
• umbilical cord mesenchymal stem cells combined with collagen scaffold
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.

Locations

Country	Name	City	State
China	Sir Run Run Shaw hopital,School of medicine,Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pregnancy rate	pregnancy rate = (pregnancy / observations) × 100%	pregnancy rate at 1 year
Secondary	live birth rate	live birth rate = (live births / observations) × 100%	live birth rate at 1 year
Secondary	abortion rate	abortion rate = (number of abortions / observations) × 100%	abortion rate at 1 year