Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
NCT Number: NCT05495711
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.
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Notify Me20 year–39 year
Female
Interventional
Phase 1
Changsha, Hunan, 410008, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 * 10^7 cells (2ml)
intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time
Time frame: 12 months
Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate.
Time frame: 12 months
Evaluated by Ultrasound B. The endometrium thickness increased ≥ 2mm and "B" or "A" endometrium appeared in the endometrium proliferation stage.
Time frame: 12 months
Evaluated by Menstrual Blood Volume Scale. The menstrual cycle returned to normal and menstrual volume improved.
Time frame: 12 months
The criterion is clinical pregnancy and supplemented with ERT detection.
Sclnow Biotechnology Co., Ltd.
Industry
A Clinical Research on Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) Therapy for Patients With Thin Endometrial Infertility
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