The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury, and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in Healing Poor After Uterus Injury disease
This is a random, open label, and self-control experiment. 10 patients are selected and sign consent forms, then divided into one group. Doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of healing Poor after Uterus Injury (Menstrual conditions, Visual analogue scale, 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 3 and 6 month after treatment, and do efficacy evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times
2 \* 10\^7 cells (2ml)
Xiangya Hospital Central South University
Changsha, Hunan, China
Intrauterine adhesion patients efficacy evaluation
Evaluate the efficacy by calculating the thickness of endometrium, the equation is, Efficacy = (thickness of endometrium after treatment - thickness of endometrium before treatment)/thickness of endometrium before treatment \* 100% Classified the efficacy in 4 grade as follow, A. Recovery, efficacy 86% - 100%; B. Obvious improve, efficacy 46% - 85%; C. Improve, efficacy 16% -45%; D. Invalid, efficacy \< 16% Grade A, B, and C is proposed to be effective.
Time frame: 12 months
Incision lacuna and incision diverticulum patients efficacy evaluation
Evaluate the efficacy by calculating the 50% or more reduction, the equation is, Efficacy = (Area of lacuna and diverticulum after treatment - Area of lacuna and diverticulum after treatment before treatment)/Area of lacuna and diverticulum before treatment \* 100%. Classified the efficacy in 4 grade as follow, A. Recovery, efficacy 86% - 100%; B. Obvious improve, efficacy 46% - 85%; C. Improve, efficacy 16% -45%; D. Invalid, efficacy \< 16% Grade A, B, and C is proposed to be effective.
Time frame: 12 months
Ultrasound of uterus evaluation
Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment.
Time frame: 12 months
Hysteroscopy evaluation
Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment.
Time frame: 12 months
Pain score
Measure the pain score of patients by Visual Analog Score (VAS) for pain
Time frame: 12 months
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