Clinical trial NCT03386708: hUC Mesenchymal Stem Cells (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterus; Injury
Keywords: Healing Poor After Uterus Injury, Mesenchymal Stem Cell
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intrauterine adhesion patients efficacy evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Incision lacuna and incision diverticulum patients efficacy evaluation
timeFrame: 12 months
measure: Ultrasound of uterus evaluation
timeFrame: 12 months
measure: Hysteroscopy evaluation
timeFrame: 12 months
measure: Pain score
timeFrame: 12 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Weishe Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.