Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis (NCT04610359) | Clinical Trial Compass
UnknownPhase 1
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis
South Korea3 participantsStarted 2020-10-20
Plain-language summary
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
Who can participate
Age range20 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 electrostimul…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: One month after stem cell injection
2
Incidence of Treatment-Emergent Adverse Events
Timeframe: Three months after stem cell injection
3
Incidence of Treatment-Emergent Adverse Events
Timeframe: Six months after stem cell injection
4
Incidence of Treatment-Emergent Adverse Events
Timeframe: Nine months after stem cell injection
5
Incidence of Treatment-Emergent Adverse Events
Timeframe: Twelve months after stem cell injection