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

NCT ID: NCT03386708

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-09-21

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.

Conditions

Uterus; Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hUC-MSC intrauterine injection group

Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)

Group Type: EXPERIMENTAL

intrauterine injection

Intervention Type: PROCEDURE

intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times

human umbilical cord mesenchymal stem cell

Intervention Type: BIOLOGICAL

2 \* 10\^7 cells (2ml)

Interventions

intrauterine injection

intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times

Intervention Type: PROCEDURE

human umbilical cord mesenchymal stem cell

2 \* 10\^7 cells (2ml)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weishe Zhang

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

Xiangya Hospital Central South University

Changsha, Hunan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35241151 (View on PubMed)

Other Identifiers

SCLnow-XY-01

Identifier Type: -

Identifier Source: org_study_id