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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Warsaw

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

17 Dec 2024 → ongoing

Decision date (initial)

2025-01-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518657-42-00

EudraCT number

2021-003336-84

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective of the study is to assess the safety of using L-PRF in the treatment of critical limb ischemia

Secondary objectives 1

1. The secondary objective of the study is a preliminary assessment of the effectiveness of using L-PRF in the treatment of critical limb ischemia, expressed as: 2.1. Mortality rate. 2.2. Limb amputation rate. 2.3. Time to revascularization of the treated limb. 2.4. Amputation-free survival time. 2.5. Muscle perfusion assessed radiologically. 2.6. Ankle-brachial index value. 2.7. Change in ischemia scores (Rutherford, WiFi). 2.8. Quality of life score (VascuQol-6).

Conditions and MedDRA coding

critical limb ischemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. To finalize ICF for participation in the study and post-operative rehabilitation.
2. Symptomatic occlusive atherosclerosis of the lower limb arteries at stages 4 and 5 of the Rutherford scale (critical limb ischemia) confirmed clinically and hemodynamically.
3. Patients aged 18 years and older, under 90 years old.
4. Patients without absolute contraindications for undergoing revascularization procedures.
5. 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).

Exclusion criteria 10

1. To not accept the ICF to participate in the clinical study.
2. Projected life time shorter than 3 years.
3. Active cancer (5-year washout period after treatment completion).
4. Other comorbidities that shorten the expected survival time to <3 years.
5. Neurological or psychiatric conditions that, in the investigator's opinion, would prevent adequate cooperation.
6. 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).
7. Absolute contraindications for the use of contrast agents (iodine-based, gadolinium-based, or 18FDG (18F-fluorodeoxyglucose)).
8. Participation in any other clinical trial or therapeutic experiment (washout period of no less than 120 days)
9. 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.
10. 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit.

Secondary endpoints 1

1. Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Warsaw

Sponsor organisation

Medical University Of Warsaw

Address

Ul. Zwirki I Wigury 61

City

Warsaw

Postcode

02-091

Country

Poland

Scientific contact point

Organisation

Medical University Of Warsaw

Contact name

Tomasz Ostrowski

Public contact point

Organisation

Medical University Of Warsaw

Contact name

Tomasz Ostrowski

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications