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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

Brief Summary:
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Stem Cell Transplant Mesenchymal Stem Cell Drug: MR-MC-01 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stem cell group
Interstitial cystitis patients who receive submucosal injection of hESC-MSCs
Drug: MR-MC-01
Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04610359


Contacts
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Contact: Myung-Soo Choo, M.D, Ph.D +82230103735 mschoo@amc.seoul.kr

Locations
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Korea, Republic of
Department of Urology, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Myung-Soo Choo, professor    82-2-3010-3735    mschoo@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
MIRAE CELL BIO
Investigators
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Principal Investigator: Myung-Soo Choo, M.D, Ph.D Professor, Asan Medical Center
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Responsible Party: Myung-Soo Choo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04610359    
Other Study ID Numbers: 2019-1451
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases