hUC Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility

NCT ID: NCT05495711

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-11-01

Brief Summary

To explore the therapeutic effect and safety of human umbilical cord mesenchymal stem cells on thin endometrial infertility and to explore whether human umbilical cord mesenchymal stem cells using collagen as the carrier can promote endometrial growth, reduce the recurrence rate of intrauterine adhesion, increase the clinical pregnancy rate, improve the pregnancy outcome, and study its safety.

Detailed Description

This is a random, open label, and self-control experiment. 24 patients are selected and sign consent forms, then divided into two groups. Doctors collect the basic information of patient (including age, BMI, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of thin endometrial infertility (menstrual conditions, uterine cavity form, pregnancies).

All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 1, 3, 6, 12 month after treatment, and do efficacy evaluation.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

stem cell and collagen transplantation group

Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT)

Group Type: EXPERIMENTAL

human umbilical cord mesenchymal stem cell complex collagen

Intervention Type: BIOLOGICAL

1 \* 10\^7 cells (2ml)

control group

collagen transplantation

Group Type: ACTIVE_COMPARATOR

intrauterine injection

Intervention Type: PROCEDURE

intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time

human umbilical cord mesenchymal stem cell complex collagen

Intervention Type: BIOLOGICAL

1 \* 10\^7 cells (2ml)

Interventions

intrauterine injection

intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time

Intervention Type: PROCEDURE

human umbilical cord mesenchymal stem cell complex collagen

1 \* 10\^7 cells (2ml)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patients aged 20 to 39 years with primary or secondary infertility who have received ivf embryo transfer treatment and have been frozen at least 4 good quality embryos (good quality embryos defined as 7-9C / ⅱ 0 or 4BC or more blastocysts and ≥2 grade ⅰ embryos or 4BC or more blastocysts)

2. Once above 2 times under hysteroscopy surgery adhesions, uterine cavity form has returned to normal, with normal menstrual cycle or at least a cycle high-dose estrogen replacement therapy for more than 12 days (> 4 mg/day, maximum dose of more than 8 mg/day), after treatment the biggest endometrial thickness of 7 mm or less or upper middle period of endometrial thickness of 7 mm or less on average; Or received assisted reproductive therapy, after at least 4mg/ day of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs, unknown maximum endometrial thickness ≤7mm or average endometrial thickness ≤7mm in middle and upper segment; The maximum endometrial thickness in luteal phase was less than 6mm

3. 18kg/m2< body mass index (BMI) <24 kg/m2

4. Voluntarily participate and sign the informed consent

5. Negative coV-19 nucleic acid test

Exclusion Criteria

1. Uncured sexually transmitted diseases

2. Participate in other clinical investigators within 3 months

3. Serum pregnancy tested positive

4. Coagulopathy or other diseases of the blood system

5. Severe heart disease, unstable angina attack, cardiac insufficiency of grade III or above, acute myocardial infarction and/or old myocardial infarction, hypertension was diagnosed according to the guidelines for prevention and treatment of hypertension in China (2010 edition)

6. Patients with active genital tuberculosis

7. Patients with immune system disorders

8. Diseases related to pregnancy outcome (any) : Untreated hydrosalpinx, untreated uterine polyp, untreated uterine infection, phase III ~ Ⅳ endometriosis and adenomyosis of the uterus, ovarian cyst > 4 cm, uterine fibroids > 2 cm in diameter, multiple muscle intramural myoma, and submucosal fibroids, cesarean section incision site benign tumor prognosis, basin celiac > 4 cm, pituitary tumors and malignant tissues and organs tumors

9. Abnormal uterine bleeding

10. Severe liver and kidney function injury, namely, blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were 2.5 times higher than the upper limit of normal value, and blood creatinine (Cr) and urea nitrogen (BUN) were 2 times higher than the upper limit of normal value

11. The researcher considers that she is not suitable for this study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

SCLnow-XY-05

Identifier Type: -

Identifier Source: org_study_id