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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.

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

Condition or disease Intervention/treatment Phase
Uterus; Injury Procedure: intrauterine injection Procedure: intravenous injection Biological: umbilical cord mesenchymal stem cell Drug: Normal saline (NS) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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/ 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)

Placebo Comparator: NS intrauterine injection group
Normal saline (NS) (2ml)
Procedure: intrauterine injection
intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/ 15 days, total 4 times

Drug: Normal saline (NS)
Treat patient with Normal saline (NS): 2ml/30ml
Other Name: placebo group

Experimental: hUC-MSC intravenous injection group
Umbilical cord mesenchymal stem cells (SCLnow 19#)
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)

Placebo Comparator: NS intravenous injection group
Normal saline (NS) (30ml)
Procedure: intravenous injection
intravenous injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/ 15 days, total 4 times

Drug: Normal saline (NS)
Treat patient with Normal saline (NS): 2ml/30ml
Other Name: placebo group




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. Ultrasound of uterus evaluation [ Time Frame: 12 months ]
    Ultrasound of uterus. Compare with the baseline images, evaluate the changes/improvement after cell treatment.

  3. Hysteroscopy evaluation [ Time Frame: 12 months ]
    Do hysteroscopy examination, compare with the baseline images, evaluate the change/improvement after cell treatment.

  4. Pain score [ Time Frame: 12 months ]
    Measure the pain score of patients by Visual Analog Score (VAS) for pain



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386708


Contacts
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Contact: Lei Guo 861064368977 georgeguo@sclnow.com

Locations
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China, Hunan
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Weishe Zhang Xiangya Hospital of Central South University

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Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03386708     History of Changes
Other Study ID Numbers: SCLnow-XY-01
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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

Keywords provided by Sclnow Biotechnology Co., Ltd.:
Healing Poor After Uterus Injury, Mesenchymal Stem Cell

Additional relevant MeSH terms:
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Wounds and Injuries