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

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

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

Study Overview

• Status: Completed
• Conditions: Uterus; Injury
• Intervention / Treatment: Procedure: intrauterine injection; Biological: human umbilical cord mesenchymal stem cell

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hUC-MSC intrauterine injection group; Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)	Procedure: intrauterine injection; intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times; Biological: human umbilical cord mesenchymal stem cell; 2 * 10^7 cells (2ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Sclnow Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Weishe Zhang, Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Healing Poor After Uterus Injury, Mesenchymal Stem Cell
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: SCLnow-XY-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No