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

October 26, 2020 updated by: Myung-Soo Choo, Asan Medical Center

Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Department of Urology, Asan Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
One month after stem cell injection
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
Three months after stem cell injection
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
Six months after stem cell injection
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
Nine months after stem cell injection
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
Twelve months after stem cell injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 Pain from baseline, 1, 3, 6, and 12 months after stem cell injection
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 PUF score from baseline, 1, 3, 6, 12 months after stem cell injection
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 ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection
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 voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection
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)
Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asan Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MIRAE CELL BIO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Myung-Soo Choo, M.D, Ph.D, Professor, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-1451

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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