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

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610359
• Other study ID #: 2019-1451
• Status: Recruiting
• Phase: Phase 1
• Start date: October 20, 2020
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Asan Medical Center
• Contact: Myung-Soo Choo, M.D, Ph.D
• Phone: +82230103735
• Email: mschoo[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Mesenchymal Stem Cell
• Stem Cell Transplant

Intervention

Drug:
• MR-MC-01
Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	MIRAE CELL BIO

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events (TEAEs)	Any TEAEs reported by patients or assessed by laboratory and image work up	One month after stem cell injection
Primary	Incidence of Treatment-Emergent Adverse Events	Any TEAEs reported by patients or assessed by laboratory and image work up	Three months after stem cell injection
Primary	Incidence of Treatment-Emergent Adverse Events	Any TEAEs reported by patients or assessed by laboratory and image work up	Six months after stem cell injection
Primary	Incidence of Treatment-Emergent Adverse Events	Any TEAEs reported by patients or assessed by laboratory and image work up	Nine months after stem cell injection
Primary	Incidence of Treatment-Emergent Adverse Events	Any TEAEs reported by patients or assessed by laboratory and image work up	Twelve months after stem cell injection
Secondary	Changes of pain after stem cell injection	Assessed by VAS (Visual Analog Scale)	Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection
Secondary	Changes of PUF (Pelvic Pain and Urgency/Frequency) scores after stem cell injection	Assessed by PUF questionnaire	Changes of PUF score from baseline, 1, 3, 6, 12 months after stem cell injection
Secondary	Changes of ICQ (O'Leary-Sant interstitial cystitis symptom index/problem index) scores after stem cell injection	Assessed by ICQ questionnaire	Changes of ICQ scores from baseline, 1, 3, 6, 12 months after stem cell injection
Secondary	Changes of voiding profiles after stem cell injection	Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume)	Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection
Secondary	Changes of Hunner lesion after stem cell injection	Assessed by cystoscopy (number, sized, location)	Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection