A multi-centric non randomized,open label, single arm trial to determine the efficacy, safety and tolerability of Tissue EngineeredXenograft (Tissue Engineered Bovine Pericardium, Tissue Engineered Bovine Jugular Vein,Tissue Engineered Porcine Pulmonary Artery) in patients with structural heart disease andpulmonary stenosis.

Frontier Lifeline Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.TOF with pulmonary Atresia
•2.DORV with pulmonary Atresia
•3.Reoperations for patients operated for TOF requiring pulmonary valve replacement
•4.Truncus Arteriosus
•5.TOF with Absent pulmonary valve
•6.Ross procedure (RVOT reconstruction)

•Subjects, who already has a implanted xenograft
•Subjects on tube feedings.
•Subjects using immunotherapy, or cytotoxic chemotherapy within 60 days before enrollment. Systemic steroids 30 days prior to enrollment. Topical therapy other than steroidal upto 7 days prior to enrollment.
•Subjects who are HIV, HBV, HCV positive.
•Subjects with hepatic, renal, or metabolic disease that is likely to interfere with the subjectâ??s participation in or completion of the study.
•Subjects having any condition that would interfere with xenografting (e.g.: connective tissue disorder, immune disorder and clinical obesity).
•Subjects who are malnourished.
•Subjects with known hypersensitivity reactions.
•Subjects who currently smoke, alcohol or any addiction.
•Subjects who have participated in any other clinical study, 3 months prior to this trial.
•Subjects who are unwilling or unable to comply with the study procedures.
•Subjects who are considered to be unsuitable candidates by the investigator, for any reason.

发起方

Frontier Lifeline Hospital