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

NCT04610359 | Unknown Phase 1

• 1 other identifier: 2019-1451
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Interstitial Cystitis; Stem Cell Transplant; Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

Study Arms (1)

Stem cell group

EXPERIMENTAL

Interstitial cystitis patients who receive submucosal injection of hESC-MSCs

Drug: MR-MC-01

Interventions

MR-MC-01 DRUG

Submucosal injection of 2.0 x 10,000,000/5ml (1mL \* 5 sites)

Stem cell group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead
• MIRAE CELL BIO: collaborator

Study Sites (1)

Department of Urology, Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Related Publications (1)

• Kyung YS, Hong KS, Chung HM, Hyun Shin J, Choo MS, Kim EY, Shin JM, Kang AR, Seo JW, Park J, Park SP. A single-center, phase 1/2a trial of hESC-derived mesenchymal stem cells (MR-MC-01) for safety and efficacy in interstitial cystitis patients. Stem Cells Transl Med. 2025 May 19;14(5):szaf018. doi: 10.1093/stcltm/szaf018.

  PMID: 40387787 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Myung-Soo Choo, M.D, Ph.D

  Professor, Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myung-Soo Choo, M.D, Ph.D

CONTACT

+82230103735; mschoo@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 30, 2020
• Study Start: October 20, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

KR (1)