Tissue Engineered Veins in Patients With Chronic Venous Insufficiency (TECVI-1)
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|ClinicalTrials.gov Identifier: NCT03784131|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2018
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Venous Insufficiency||Drug: P-TEV||Phase 1|
The advanced therapy medicinal product (ATMP) described herein is a personalized tissue- engineered vein (P-TEV), a human vein segment graft for use in transplantation to replace a defective or missing part of a patient's vein.
In this specific application a P-TEV segment with a functioning venous bicuspid valve is implanted to replace a nonfunctioning venous valve in the femoral vein of a patient suffering from severe CVI. The P-TEV is a hybrid tissue consisting of the extracellular matrix (ECM) scaffold of an allogeneic vein segment derived from a cadaveric donor as well as autologous components from a sample of peripheral blood of the recipient. As the allogeneic immunogenic material from the donor has been removed and been replaced by autologous components, no immunosuppression is required.
Successful implantation and treatment should prevent the reverse flow of blood, decrease blood pooling in the lower leg, and thereby alleviate symptoms such as swelling, pain, and ulcers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Open-label, First-in-human Study to Evaluate Feasibility and Safety of Tissue Engineered Veins in Patients With Chronic Venous Insufficiency|
|Estimated Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: Personalized Tissue Engineered Vein
Replacement of vein with failing valves with personalized tissue engineering vein containing functional valves
- Thrombosis leading to occlusion of the graft measured by Color Duplex Ultrasound [ Time Frame: 12 months ]Ultrasonographic evaluation of occlusions of the graft.
- Infection leading to surgical excision of the graft measured by blood samples [ Time Frame: 12 months ]White blood cells count: >10 x10E9/L, C- Reactive Protein (CRP): >4 mg/L, sedimentation rate: >12mm).
- Infection leading to surgical excision of the graft measured by Color Duplex Ultrasound [ Time Frame: 12 months ]Ultrasonographic examination to assess infection of the graft
- Infection leading to surgical excision of the graft measured by Computer Tomography [ Time Frame: 12 months ]Infection of the graft assessed by Computer Tomography
- Reporting of surgical complications [ Time Frame: 12 months ]Perioperative surgical complications related to the implanted graft (technical failure leading to surgical failure).
- Change in symptoms assessed according to VCSS (Venous Clinical Severity Score) [ Time Frame: 12 months ]The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 (absent) to 3 (severe), plus a category for compression with higher scores representing greater compliance (still scale 0-3).
- Change in symptoms assessed according to CEAP classification (clinical, etiologic, anatomic, pathophysiologic) [ Time Frame: 12 months ]CEAP classification is assessed on scale from C0 (No visible or palpable signs of venous disease) to C6 (Active venous ulcer).
- Health Related Quality of Life assessed by VEINES questionnaire [ Time Frame: 12 months ]Responses are made on a 2- to 7-point scale that rates intensity, frequency, and agreement. Higher scores are associated with better quality-of-life.The focus of VEINES is on physical symptoms as opposed to psychological or social aspects.
- Health Related Quality of Life assessed by EQ-5D questionnaire [ Time Frame: 12 months ]
EQ-5D is a standardized self-assessment instrument for health status.It has two components; health state description and evaluation.
The description part contains 5 items with three levels of response regarding five dimensions (mobility, hygiene, activities, pain and anxiety). The five questions are compounded into a health index according to a mathematical formula validated against the population in several countries. This index may vary between 1 and -0,594.
- Durability of the P-TEV assessed by Color Duplex Ultrasound [ Time Frame: 12 months ]The time period in which the valve contained in the implant retains its function verified by ultrasonographic examination.
- Vessel dilatation in the implant assessed by Duplex Color Ultrasound [ Time Frame: 12 months ]Ultrasonographic examination of vessel dilatation
- Flow abnormalities in the implant assessed by Duplex Color Ultrasound [ Time Frame: 12 months ]Ultrasonographic examination of flow abnormalities
- Wall degeneration in the implant assessed by Duplex Color Ultrasound [ Time Frame: 12 months ]Ultrasonographic examination of wall degeneration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784131
|Contact: Petter Björquistfirstname.lastname@example.org|