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

Primary Purpose

Interstitial Cystitis, Stem Cell Transplant, Mesenchymal Stem Cell

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MR-MC-01
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Urology, Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell group

Arm Description

Interstitial cystitis patients who receive submucosal injection of hESC-MSCs

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (TEAEs)
Any TEAEs reported by patients or assessed by laboratory and image work up
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up
Incidence of Treatment-Emergent Adverse Events
Any TEAEs reported by patients or assessed by laboratory and image work up

Secondary Outcome Measures

Changes of pain after stem cell injection
Assessed by VAS (Visual Analog Scale)
Changes of PUF (Pelvic Pain and Urgency/Frequency) scores 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
Assessed by ICQ questionnaire
Changes of voiding profiles 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
Assessed by cystoscopy (number, sized, location)

Full Information

First Posted
October 19, 2020
Last Updated
October 26, 2020
Sponsor
Asan Medical Center
Collaborators
MIRAE CELL BIO
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1. Study Identification

Unique Protocol Identification Number
NCT04610359
Brief Title
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis
Official Title
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
MIRAE CELL BIO

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Stem Cell Transplant, Mesenchymal Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem cell group
Arm Type
Experimental
Arm Description
Interstitial cystitis patients who receive submucosal injection of hESC-MSCs
Intervention Type
Drug
Intervention Name(s)
MR-MC-01
Intervention Description
Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Description
Any TEAEs reported by patients or assessed by laboratory and image work up
Time Frame
One month after stem cell injection
Title
Incidence of Treatment-Emergent Adverse Events
Description
Any TEAEs reported by patients or assessed by laboratory and image work up
Time Frame
Three months after stem cell injection
Title
Incidence of Treatment-Emergent Adverse Events
Description
Any TEAEs reported by patients or assessed by laboratory and image work up
Time Frame
Six months after stem cell injection
Title
Incidence of Treatment-Emergent Adverse Events
Description
Any TEAEs reported by patients or assessed by laboratory and image work up
Time Frame
Nine months after stem cell injection
Title
Incidence of Treatment-Emergent Adverse Events
Description
Any TEAEs reported by patients or assessed by laboratory and image work up
Time Frame
Twelve months after stem cell injection
Secondary Outcome Measure Information:
Title
Changes of pain after stem cell injection
Description
Assessed by VAS (Visual Analog Scale)
Time Frame
Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection
Title
Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection
Description
Assessed by PUF questionnaire
Time Frame
Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection
Title
Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection
Description
Assessed by ICQ questionnaire
Time Frame
Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection
Title
Changes of voiding profiles after stem cell injection
Description
Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume)
Time Frame
Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection
Title
Changes of Hunner lesion after stem cell injection
Description
Assessed by cystoscopy (number, sized, location)
Time Frame
Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Soo Choo, M.D, Ph.D
Phone
+82230103735
Email
mschoo@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung-Soo Choo, M.D, Ph.D
Organizational Affiliation
Professor, Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Soo Choo, professor
Phone
82-2-3010-3735
Email
mschoo@amc.seoul.kr

12. IPD Sharing Statement

Learn more about this trial

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

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