Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hUC-MSC intrauterine injection group | Experimental | Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrauterine injection | Procedure | intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weishe Zhang | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35241151 | Derived | Huang J, Li Q, Yuan X, Liu Q, Zhang W, Li P. Intrauterine infusion of clinically graded human umbilical cord-derived mesenchymal stem cells for the treatment of poor healing after uterine injury: a phase I clinical trial. Stem Cell Res Ther. 2022 Mar 3;13(1):85. doi: 10.1186/s13287-022-02756-9. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| human umbilical cord mesenchymal stem cell | Biological | 2 * 10^7 cells (2ml) |
|
| 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 |