Clinical trial NCT04610359: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Interstitial Cystitis
Stem Cell Transplant
Mesenchymal Stem Cell
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: MIRAE CELL BIO
First posted: 2020-10-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: One month after stem cell injection
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Three months after stem cell injection
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Six months after stem cell injection
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Nine months after stem cell injection
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Twelve months after stem cell injection
Secondary outcomes:
measure: Changes of pain after stem cell injection
timeFrame: Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection
measure: Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection
timeFrame: Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection
measure: Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection
timeFrame: Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection
measure: Changes of voiding profiles after stem cell injection
timeFrame: Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection
measure: Changes of Hunner lesion after stem cell injection
timeFrame: Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Asan Medical Center
Study officials:
affiliation: Professor, Asan Medical Center
name: Myung-Soo Choo, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: