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

Phase 1

Completed

• Conditions: Uterus; Injury
• Interventions: Procedure: intrauterine injection; Biological: human umbilical cord mesenchymal stem cell

• Registration Number: NCT03386708
• Lead Sponsor: Sclnow Biotechnology Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2018-10-01
• Primary Completion: 2021-06-01
• Status Verified: 2021-09
• Study Completion: 2021-09-21
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hUC-MSC intrauterine injection group	human umbilical cord mesenchymal stem cell	Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)
hUC-MSC intrauterine injection group	intrauterine injection	Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China