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the Safety/Efficacy of Umbilical Cord Mesenchymal Stem Cell (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury

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ClinicalTrials.gov Identifier: NCT03386708
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 29, 2017
Last Update Posted Date February 15, 2019
Estimated Study Start Date  ICMJE February 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
Intrauterine adhesion patients efficacy evaluation [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03386708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • Incision lacuna and incision diverticulum patients efficacy evaluation [ Time Frame: 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 [ Time Frame: 12 months ]
    Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment.
  • Hysteroscopy evaluation [ Time Frame: 12 months ]
    Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment.
  • Pain score [ Time Frame: 12 months ]
    Measure the pain score of patients by Visual Analog Score (VAS) for pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Safety/Efficacy of Umbilical Cord Mesenchymal Stem Cell (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury
Official Title  ICMJE 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
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 parallel controled experiment. 40 patients are selected and sign consent forms, then divided into four groups. 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 1, 2, 3, 6, and 12 month after treatment, and do efficacy evaluation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterus; Injury
Intervention  ICMJE
  • Procedure: intrauterine injection
    intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/ 15 days, total 4 times
  • Procedure: intravenous injection
    intravenous injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/ 15 days, total 4 times
  • Biological: umbilical cord mesenchymal stem cell
    Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), intrauterine injection: 2 * 10^7 cells (2ml)/ intravenous injection: 4 * 10^7 cells (30ml)
  • Drug: Normal saline (NS)
    Treat patient with Normal saline (NS): 2ml/30ml
    Other Name: placebo group
Study Arms  ICMJE
  • Experimental: hUC-MSC intrauterine injection group
    Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)
    Interventions:
    • Procedure: intrauterine injection
    • Biological: umbilical cord mesenchymal stem cell
  • Placebo Comparator: NS intrauterine injection group
    Normal saline (NS) (2ml)
    Interventions:
    • Procedure: intrauterine injection
    • Drug: Normal saline (NS)
  • Experimental: hUC-MSC intravenous injection group
    Umbilical cord mesenchymal stem cells (SCLnow 19#)
    Interventions:
    • Procedure: intravenous injection
    • Biological: umbilical cord mesenchymal stem cell
  • Placebo Comparator: NS intravenous injection group
    Normal saline (NS) (30ml)
    Interventions:
    • Procedure: intravenous injection
    • Drug: Normal saline (NS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female, with BMI 19-25 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 >50
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lei Guo 861064368977 georgeguo@sclnow.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03386708
Other Study ID Numbers  ICMJE SCLnow-XY-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sclnow Biotechnology Co., Ltd.
Study Sponsor  ICMJE Sclnow Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Weishe Zhang Xiangya Hospital of Central South University
PRS Account Sclnow Biotechnology Co., Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP