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NCT Number: NCT03386708

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

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

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Key information

Conditions

Uterus; Injury Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intrauterine injection

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

Biological

2 * 10^7 cells (2ml)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sclnow Biotechnology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2017
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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