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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Uterus; Injury
- Sponsor
- Sclnow Biotechnology Co., Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Intrauterine adhesion patients efficacy evaluation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Intrauterine adhesion patients efficacy evaluation
Time Frame: 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 Outcomes
- Incision lacuna and incision diverticulum patients efficacy evaluation(12 months)
- Ultrasound of uterus evaluation(12 months)
- Hysteroscopy evaluation(12 months)
- Pain score(12 months)