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

NCT05495711 | Completed Phase 1

• 1 other identifier: SCLnow-XY-05
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

Thin Endometrial Infertility; hUCMSCs

Outcome Measures

Primary Outcomes (1)

• Pregnancy outcome

  Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.

  12 months

Secondary Outcomes (3)

• Intrauterine adhesion patients efficacy evaluation

  12 months

• Irregular menstruation patients efficacy evaluation

  12 months

• Poor endometrial receptivity patients efficacy evaluation

  12 months

Study Arms (2)

stem cell and collagen transplantation group

EXPERIMENTAL

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

Biological: human umbilical cord mesenchymal stem cell complex collagen

control group

ACTIVE COMPARATOR

collagen transplantation

Biological: human umbilical cord mesenchymal stem cell complex collagen; Procedure: intrauterine injection

Interventions

human umbilical cord mesenchymal stem cell complex collagen BIOLOGICAL

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

control group; stem cell and collagen transplantation group

intrauterine injection PROCEDURE

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

control group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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
• kg/m2\< body mass index (BMI) \<24 kg/m2
• Voluntarily participate and sign the informed consent
• Negative coV-19 nucleic acid test

You may not qualify if:

• Uncured sexually transmitted diseases
• Participate in other clinical investigators within 3 months
• Serum pregnancy tested positive
• Coagulopathy or other diseases of the blood system
• 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)
• Patients with active genital tuberculosis
• Patients with immune system disorders
• 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
• Abnormal uterine bleeding
• 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
• The researcher considers that she is not suitable for this study

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: randomize double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 10, 2022
• Study Start: August 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)