Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    3
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
Study Started
Oct 20
2020
Primary Completion
Oct 31
2022
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Oct 30
2020

Drug MR-MC-01

Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)

Stem cell group Experimental

Interstitial cystitis patients who receive submucosal injection of hESC-MSCs

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
No Results Posted