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

Asan Medical Center

Status and phase: Unknown; Phase 1

Conditions: Stem Cell Transplant; Interstitial Cystitis; Mesenchymal Stem Cell

Treatments: Drug: MR-MC-01

Study type: Interventional

Funder types: Other

Identifiers

NCT04610359

2019-1451

Details and patient eligibility

About

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

Enrollment: 3 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Stem cell group

Experimental group

Description:

Interstitial cystitis patients who receive submucosal injection of hESC-MSCs

Treatment:

Drug: MR-MC-01