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

Asan Medical Center1 site in 1 country3 target enrollmentOctober 20, 2020

ConditionsInterstitial Cystitis Stem Cell Transplant Mesenchymal Stem Cell

InterventionsMR-MC-01

DrugsMR-MC-01

Overview

Phase: Phase 1
Intervention: MR-MC-01
Conditions: Interstitial Cystitis
Sponsor: Asan Medical Center
Enrollment: 3
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events (TEAEs)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 20, 2020

End Date

December 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

Myung-Soo Choo

Professor

Asan Medical Center

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

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

Arms & Interventions

Stem cell group

Interstitial cystitis patients who receive submucosal injection of hESC-MSCs

Intervention: MR-MC-01

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time Frame: One month after stem cell injection

Any TEAEs reported by patients or assessed by laboratory and image work up

Incidence of Treatment-Emergent Adverse Events

Time Frame: Twelve months after stem cell injection

Any TEAEs reported by patients or assessed by laboratory and image work up

Secondary Outcomes

Changes of pain after stem cell injection(Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection)
Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection(Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection)
Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection(Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection)
Changes of voiding profiles after stem cell injection(Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection)
Changes of Hunner lesion after stem cell injection(Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection)