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

Phase 1

• Conditions: Stem Cell Transplant; Mesenchymal Stem Cell; Interstitial Cystitis
• Interventions: Drug: MR-MC-01

• Registration Number: NCT04610359
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-19
• Study Start: 2020-10-20
• Study First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell group	MR-MC-01	Interstitial cystitis patients who receive submucosal injection of hESC-MSCs

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (TEAEs)	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	Twelve months after stem cell injection	Any TEAEs reported by patients or assessed by laboratory and image work up

Secondary Outcome Measures

Name	Time	Method
Changes of pain after stem cell injection	Changes of Pain from baseline, 1, 3, 6, and 12 months after stem cell injection	Assessed by VAS (Visual Analog Scale)
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	Assessed by PUF questionnaire
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	Assessed by ICQ questionnaire
Changes of voiding profiles after stem cell injection	Changes of voiding profiles from baseline, 1, 3, 6, 12 months after stem cell injection	Assessed by voiding diary (frequency, nocturia, urgency, urge incontinence and mean voided volume)
Changes of Hunner lesion after stem cell injection	Changes of Hunner lesion from baseline, 1, 3, 6, 12 months after stem cell injection	Assessed by cystoscopy (number, sized, location)

Trial Locations

Locations (1)

Department of Urology, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of