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

Uterus; Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386708
• Other study ID #: SCLnow-XY-01
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2018
• Est. completion date: September 21, 2021

Study information

• Verified date: September 2021
• Source: Sclnow Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 21, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Uterus; Injury
• Wounds and Injuries

Intervention

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)

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Ultrasound of uterus evaluation	Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment.	12 months
Secondary	Hysteroscopy evaluation	Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment.	12 months
Secondary	Pain score	Measure the pain score of patients by Visual Analog Score (VAS) for pain	12 months