hUC Mesenchymal Stem Cells (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cell (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury

Conditions
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Uterus; Injury

Intervention / Treatment
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* Procedure: intrauterine injection
* Biological: human umbilical cord mesenchymal stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, with BMI 18-24 kg/m^2 Meet the clinical standard of Healing Poor After Uterus Injury Non smoker Do not accept stem cells treatment in 6 months Participants or their family members sign the consent form of this study Exclusion Criteria: Pregnant or breast feeding women Age <18 or >40 Refuse to sign the consent form Patients with underlying risk of medical disease history: history of diabetes, serious cardiovascular disease, severe infection, alimentary tract hemorrhage, etc. Serum with HIV, syphilis antibody positive Severe mental disease, cognitive disorder patients Other severe system or organ organic disease Participate other clinical experiments in 3 months Ovarian and pituitary dysfunction diseases With some other conditions that doctor propose not to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hUC-MSC intrauterine injection group<br>Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#) | Procedure: intrauterine injection<br>* intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times<br>Biological: human umbilical cord mesenchymal stem cell<br>* 2 * 10^7 cells (2ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| Ultrasound of uterus evaluation | Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment. | 12 months | 
| Hysteroscopy evaluation | Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment. | 12 months | 
| Pain score | Measure the pain score of patients by Visual Analog Score (VAS) for pain | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healing Poor After Uterus Injury, Mesenchymal Stem Cell