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Augmenting ischemia-induced vasculo- and angiogenesis after endovascular reperfusion with host-extracted, percutaneously introduced, leucocyte- and platelet-rich fibrin in patients with critical limb ischemia
EU CTIS ID: 2024-518657-42-00
What this study is testing
The primary objective of the study is to assess the safety of using L-PRF in the treatment of critical limb ischemia
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- To finalize ICF for participation in the study and post-operative rehabilitation.
- Symptomatic occlusive atherosclerosis of the lower limb arteries at stages 4 and 5 of the Rutherford scale (critical limb ischemia) confirmed clinically and hemodynamically.
- Patients aged 18 years and older, under 90 years old.
- Patients without absolute contraindications for undergoing revascularization procedures.
- Expected average survival time: more than 3 years (patients will be eligible for the study if their expected perioperative mortality is <5% and the probability of predicted 2-year survival is >50%—such patients will be classified as having medium or high surgical risk).
You likely can't join if
- To not accept the ICF to participate in the clinical study.
- Inability to qualify the patient as a tissue donor due to history or diagnostic test results aimed at detecting contraindications for being a tissue or cell donor, including the presence of biological pathogens as defined by the Act on the Procurement, Storage, and Transplantation of Cells, Tissues, and Organs (Journal of Laws 2005 No. 169 item 1411) and included in the donor qualification form for the Tissue and Cell Bank (Attachment BT01).
- Projected life time shorter than 3 years.
- Active cancer (5-year washout period after treatment completion).
- Other comorbidities that shorten the expected survival time to <3 years.
- Neurological or psychiatric conditions that, in the investigator's opinion, would prevent adequate cooperation.
See the full eligibility criteria
Who can join
- To finalize ICF for participation in the study and post-operative rehabilitation.
- Symptomatic occlusive atherosclerosis of the lower limb arteries at stages 4 and 5 of the Rutherford scale (critical limb ischemia) confirmed clinically and hemodynamically.
- Patients aged 18 years and older, under 90 years old.
- Patients without absolute contraindications for undergoing revascularization procedures.
- Expected average survival time: more than 3 years (patients will be eligible for the study if their expected perioperative mortality is <5% and the probability of predicted 2-year survival is >50%—such patients will be classified as having medium or high surgical risk).
What rules you out
- To not accept the ICF to participate in the clinical study.
- Inability to qualify the patient as a tissue donor due to history or diagnostic test results aimed at detecting contraindications for being a tissue or cell donor, including the presence of biological pathogens as defined by the Act on the Procurement, Storage, and Transplantation of Cells, Tissues, and Organs (Journal of Laws 2005 No. 169 item 1411) and included in the donor qualification form for the Tissue and Cell Bank (Attachment BT01).
- Projected life time shorter than 3 years.
- Active cancer (5-year washout period after treatment completion).
- Other comorbidities that shorten the expected survival time to <3 years.
- Neurological or psychiatric conditions that, in the investigator's opinion, would prevent adequate cooperation.
- Abnormal hematological and biochemical parameters: Hemoglobin: <9.5 g/dl, Platelet count: <50,000/mm³, Bilirubin level: 3 times above the permissible upper limit of normal, AST: 3 times above the permissible upper limit of normal, ALT: 3 times above the permissible upper limit of normal, GFR: below 30 ml/min/1.73 m² (renal failure).
- Absolute contraindications for the use of contrast agents (iodine-based, gadolinium-based, or 18FDG (18F-fluorodeoxyglucose)).
- Participation in any other clinical trial or therapeutic experiment (washout period of no less than 120 days)
- Women: pregnancy or positive pregnancy test at the time of inclusion in the study, and non-use of contraception (mechanical or hormonal), or declaration of non-use of contraception (mechanical or hormonal, except in cases of physical sterilization) during the study for premenopausal women. Women in the lactation period.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.