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

A Clinical Research on Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Biological: human umbilical cord mesenchymal stem cell complex collagen; Procedure: intrauterine injection

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stem cell and collagen transplantation group; Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT)	Biological: human umbilical cord mesenchymal stem cell complex collagen; 1 * 10^7 cells (2ml)
Active Comparator: control group; collagen transplantation	Biological: human umbilical cord mesenchymal stem cell complex collagen; 1 * 10^7 cells (2ml); Procedure: intrauterine injection; intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy outcome	Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrauterine adhesion patients efficacy evaluation	Evaluated by Ultrasound B. The endometrium thickness increased ≥ 2mm and "B" or "A" endometrium appeared in the endometrium proliferation stage.	12 months
Irregular menstruation patients efficacy evaluation	Evaluated by Menstrual Blood Volume Scale. The menstrual cycle returned to normal and menstrual volume improved.	12 months
Poor endometrial receptivity patients efficacy evaluation	The criterion is clinical pregnancy and supplemented with ERT detection.	12 months

Collaborators and Investigators

• Sponsor: Sclnow Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Thin Endometrial Infertility; hUCMSCs
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: SCLnow-XY-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No