NCT05675722招募中1 期
Phase 1 Trial Of Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quality of Life Scores
研究概览
简要总结
In this Phase 1, single site, clinical trial, Vulvar/vaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's biopsy
详细描述
The cells are expanded in vitro and seeded on scaffold and matured - The final Tissue Engineered Vagina (TEV) is implanted into the native vaginal site
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with congenital Mullerian duct anomaly that includes absence or obliteration of all or part of the vagina, as confirmed on pelvic MRI
- •Females between the ages of 15 and 45 years
- •Patients with stable medical comorbidities
- •Patients that are willing to comply with all study instructions and are willing to return for study follow-up visits
排除标准
- •Patients with a history of surgery in the target area more recent than the last 6 months
- •Patients with an active vaginal area infection or urinary infection as evidenced by clinical exam or culture result
- •Patients with a history of keloid scarring
- •Patients who are currently taking anti-platelet medications or blood thinners
- •Patients with a history of clotting disorder
- •Patients with autoimmune disease or immune disorder
- •Patients requiring concomitant use of or treatment with immunosuppressive agents
- •Patients with a history of systemic conditions, including but not limited to HIV, thrombocytopenia, uncontrolled diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study
- •Patients with evidence or diagnosis of any primary coagulation disorder (including concomitant anticoagulation therapy at enrollment)
- •Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study
- •Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
- •Patients who are current tobacco users
- •Patients with alcohol/drug abuse problems
- •Patients with any systemic disease
- •Patients with any psychiatric disorders
- •Inability to participate in all necessary study activities due to physical or mental limitations.
- •Any circumstance in which the investigator deems participation in the study is not in the subject's best interest
- •The following vital sign cut-off values, laboratory cut-off values and ECG reading will be monitored as the exclusion criteria in the biopsy visit and again before the implantation surgery BP systolic >160 or <90 millimeters of mercury (mmHg) or diastolic >100 or<60 millimeters of mercury (mmHg) Pulse <60 or >105bpm Respiratory Rate < 9 and >20 Temp > 100.4 degrees Fahrenheit Liver enzymes >2 times the upper limit of normal (ULN) Abnormal bilirubin unless subject has Gilbert's glomerular filtration rate (eGFR) < 60 mL/min/ 1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) HbA1C > 8% Hb <10 mg/dL Platelet Count <100,000 O2 saturation <95%
- •If a vital sign or lab value results in exclusion, the subject could be rescreened later
研究组 & 干预措施
autologous vaginal construct for patients with vaginal aplasia
Experimental
Biologic vaginal construct, surgically implanted into native vaginal site
干预措施: biologic vaginal-construct implantation (Biological)
结局指标
主要结局
Quality of Life Scores
时间窗: Month 36
The Quality of Life Scores (QOLS) is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112 - the higher score indicates the higher quality of life
Number of Serious Adverse Events
时间窗: Month 36
bleeding, pain, visceral injury, vaginal scarring, contraction, or infection
次要结局
- Change in Quality of life Female Sexual Function Index (FSFI) Scores(Month 3, Month 6, Month 12, and Month 36)
研究者
研究点 (1)
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