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SuspendedPhase 1

SCLife®-UT hUC-MSCs Advanced Therapy Medicinal Products (hUC-MSCs ATMPs) for Patients With Thin Endometrial Infertility

Key facts

Who runs it
Sclnow Biotechnology Co., Ltd.
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Suspended
Phase
Phase 1
People taking part
24 people, planned
Starts
31 Dec 2026
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • human umbilical cord mesenchymal stem cell complex collagen
  • intrauterine injection
Record updated
23 April 2026
Why it stopped
Lack of financial support

Who can take part

Age
20 years to 39 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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
  • 18kg/m2< body mass index (BMI) <24 kg/m2
  • Voluntarily participate and sign the informed consent
  • Negative coV-19 nucleic acid test

Who cannot take part

  • Uncured sexually transmitted diseases
  • 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
  • Serum pregnancy tested positive
  • 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
  • Participate in other clinical investigators within 3 months
  • The researcher considers that she is not suitable for this study

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • stem cell and collagen transplantation groupTreatment being tested

    Human Umbilical Cord Mesenchymal Stem Cells

    Treatment: human umbilical cord mesenchymal stem cell complex collagen

  • control groupExisting treatment, for comparison

    collagen transplantation

    Treatment: human umbilical cord mesenchymal stem cell complex collagen and intrauterine injection

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Clinical Research on SCLife®-UT hUC-MSCs Advanced Therapy Medicinal Products (hUC-MSCs ATMPs) for Patients With Thin Endometrial Infertility
Record updated
23 April 2026