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Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610359
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
MIRAE CELL BIO
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE October 19, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE October 20, 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: One month after stem cell injection ]
    Any TEAEs reported by patients or assessed by laboratory and image work up
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Three months after stem cell injection ]
    Any TEAEs reported by patients or assessed by laboratory and image work up
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Six months after stem cell injection ]
    Any TEAEs reported by patients or assessed by laboratory and image work up
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Nine months after stem cell injection ]
    Any TEAEs reported by patients or assessed by laboratory and image work up
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Twelve months after stem cell injection ]
    Any TEAEs reported by patients or assessed by laboratory and image work up
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
  • Changes of pain after stem cell injection [ Time Frame: Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection ]
    Assessed by VAS (Visual Analog Scale)
  • Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection [ Time Frame: Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection ]
    Assessed by PUF questionnaire
  • Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection [ Time Frame: Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection ]
    Assessed by ICQ questionnaire
  • Changes of voiding profiles after stem cell injection [ Time Frame: Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection ]
    Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume)
  • Changes of Hunner lesion after stem cell injection [ Time Frame: Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection ]
    Assessed by cystoscopy (number, sized, location)
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 Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis
Official Title  ICMJE Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study
Brief Summary This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Interstitial Cystitis
  • Stem Cell Transplant
  • Mesenchymal Stem Cell
Intervention  ICMJE Drug: MR-MC-01
Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)
Study Arms  ICMJE Experimental: Stem cell group
Interstitial cystitis patients who receive submucosal injection of hESC-MSCs
Intervention: Drug: MR-MC-01
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2020)		 3
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female, aged >= 20 years
  • Interstitial cystitis symptom duration more than 6 months
  • Presence of Hunner lesions in outpatient cystoscopy (within one months of screening), with size < 2cm, number <= 2
  • VAS (Visual pain analogue scale) >=4 in screening symptom questionnaire

  • Those who are suitable for stem cell transplantation

    • normal laboratory findings (hematological, chemical)
    • no history of drug abuse
    • negative HIV, HBV, HCV serology tests
    • No history of malignancies
    • willing to contraception
    • no plan for blood, tissue donation
  • Who can understand consent form and willing to participate in the study

Exclusion Criteria:

  • recurrent urinary tract infection ( more than twice per past six months or more than three times per past one year) or active urinary tract infection
  • any active or past history of tuberculosis or systemic infection
  • Anatomical abnormality of lower urinary tract

  • History of following procedures

    • stem cell transplantation In past 6 months,
    • transurethral resection/fulguration of Hunner lesion or hydrodistension of bladder
    • intravesical instillation of ialuril
    • hysterectomy, anti-incontinence surgery, transvaginal surgery, pelvic organ prolapse repair, vagina delivery or C/sec
    • any neurological conditions including cerebrovascular disease, multiple sclerosis, spinal cord injury, Parkinson disease
    • indwelling Foley catheter or intermittent catheterization
    • any plans for electrostimulation, neuromodulation, physiotherapy or operation for other organs
    • any history of malignancy
    • history of myocardiac infarction in past 12 months
    • Uncontrolled diabetes (HbAlc >= 7.2%) or diabetes requiring insulin injection
    • Uncontrolled hypertension (systolic >170mmHg or <90mmHg, diastolic >100mmHg or <50mmHg)
    • Immunodeficiency
    • Positive HBV, HCV, HIV, syphilis
    • pregnant or on breast feeding
    • any history of drug, alcohol abuse. mis-use
    • Any significant signs, symptoms or previous diagnosis of psychological disorder
    • Impossible to follow scheduled visits
    • Currently participating or participated in other clinical studies within past 3 months
    • Allergic to protein products (serum), antibiotics (gentamicin), DMSO (Dimethyl sulfoxide)
    • Any circumstances that is not suitable for participating or continuing clinical study or participants who clinical investigator considers not suitable for participation
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Myung-Soo Choo, M.D, Ph.D +82230103735 mschoo@amc.seoul.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04610359
Other Study ID Numbers  ICMJE 2019-1451
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
Current Responsible Party Myung-Soo Choo, Asan Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Asan Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE MIRAE CELL BIO
Investigators  ICMJE
Principal Investigator: Myung-Soo Choo, M.D, Ph.D Professor, Asan Medical Center
PRS Account Asan Medical Center
Verification Date October 2020

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