CTRI/2025/11/097452招募中2 期
A multi-center, single arm study to evaluate the safety, tolerability and performance of Extracorporeal Bioengineered Dual Cell Liver Regeneration System [EBDLR System] in patients suffering from Acute on Chronic Liver Failure (ACLF) and Acute Liver Failure (ALF) along with the Standard of Care (SoC).
YKRITA Life Sciences Pvt. Ltd.11 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 11
研究概览
简要总结
The device discussed in this proposal caters to this need for external-hepatic support to individuals with failing liver. EBDLR practically takes over the functions of a native liver (both synthetic and detoxification) when connected to a patient. This is a bioengineered device which has employed principles of engineering and biotechnology in sync. The engineering aspect of the device takes care of a safe method to withdraw and circulate blood and plasma through the system. Biotechnology approach ensures that the plasma is detoxified by the specialized cells present in the bio-purifier. External detoxification enables the native/injured liver to regenerate aiding the patient’s survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 years and 70 years both the genders.
- •Patients or LAR IW able to provide informed consent voluntarily to participate in the study.
- •Patients with known unknown liver disease.
- •If known, patient diagnosed with ACLF Grade 1, 2 or 3a defined as per the CLIF C OF score system.
- •Patients with no obvious decompensation or admission to hospital in the past 30 days prior to the current visit.
- •PT International Normalized Ratio 1.5 vii.
- •Bilirubin 5 mg per dL.
- •Serum Creatinine 2 mg per dL with or without ascites or encephalopathy.
- •Mean arterial pressure of 60 mmHg.
排除标准
- •Patients with hemodynamic instability not responding to modest inotropic support.
- •Patients on hemodialysis support.
- •Uncontrolled infection or sepsis that is not responding to antibiotics.
- •Patients with more than three organ system failure at presentation.
- •Patient with Acute Myocardial Infarction.
- •Signs of intracranial bleed.
- •Pregnancy
- •History of malignancy that has not been cured or any cancer in remission for less than 1 year.
- •Any other health condition that would preclude participation in the study in the judgment of the site principal investigator.
- •Patients with a known allergy to heparin or have type II thrombocytopenia caused by heparin.
- •In the opinion of the investigator, the patient is unsafe for the study can be excluded.
研究者
Dr Mahesh Gopasetty
YKRITA Life Sciences Pvt. Ltd
研究点 (11)
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