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

Primary Purpose

Uterus; Injury

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
intrauterine injection
human umbilical cord mesenchymal stem cell
Sponsored by
Sclnow Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterus; Injury focused on measuring Healing Poor After Uterus Injury, Mesenchymal Stem Cell

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Xiangya Hospital Central South University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hUC-MSC intrauterine injection group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Ultrasound of uterus evaluation
Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment.
Hysteroscopy evaluation
Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment.
Pain score
Measure the pain score of patients by Visual Analog Score (VAS) for pain

Full Information

First Posted
December 12, 2017
Last Updated
January 25, 2022
Sponsor
Sclnow Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03386708
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sclnow Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterus; Injury
Keywords
Healing Poor After Uterus Injury, Mesenchymal Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hUC-MSC intrauterine injection group
Arm Type
Experimental
Arm Description
Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)
Intervention Type
Procedure
Intervention Name(s)
intrauterine injection
Intervention Description
intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cell
Intervention Description
2 * 10^7 cells (2ml)
Primary Outcome Measure Information:
Title
Intrauterine adhesion patients efficacy evaluation
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incision lacuna and incision diverticulum patients efficacy evaluation
Description
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.
Time Frame
12 months
Title
Ultrasound of uterus evaluation
Description
Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment.
Time Frame
12 months
Title
Hysteroscopy evaluation
Description
Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment.
Time Frame
12 months
Title
Pain score
Description
Measure the pain score of patients by Visual Analog Score (VAS) for pain
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weishe Zhang
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35241151
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.
Results Reference
derived

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

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