NCT04610359Unknown1 期
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis; Open-labelled, Single Center, Phase 1 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Stem cell group
Experimental
Interstitial cystitis patients who receive submucosal injection of hESC-MSCs
干预措施: MR-MC-01 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: 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
时间窗: Twelve months after stem cell injection
Any TEAEs reported by patients or assessed by laboratory and image work up
次要结局
- 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)
研究者
Myung-Soo Choo
Professor
Asan Medical Center
研究点 (1)
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