Uterus; Injury
Conditions
Keywords
Healing Poor After Uterus Injury, Mesenchymal Stem Cell
Brief summary
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
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.
Interventions
PROCEDUREintrauterine injection
intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times
2 \* 10\^7 cells (2ml)
Sponsors
Sclnow Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrauterine adhesion patients efficacy evaluation | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incision lacuna and incision diverticulum patients efficacy evaluation | 12 months | 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. |
| Ultrasound of uterus evaluation | 12 months | Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment. |
| Hysteroscopy evaluation | 12 months | Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment. |
| Pain score | 12 months | Measure the pain score of patients by Visual Analog Score (VAS) for pain |
Countries
China
Outcome results
None listed