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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: MIRAE CELL BIO

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