HemaTrate in the Treatment of CLI
Research type
Research Study
Full title
Clinical Study of Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
IRAS ID
236402
Contact name
Bijan Modarai
Contact email
Sponsor organisation
Cook Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 2 months, 13 days
Research summary
The purpose of this international study (Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia) is to determine whether the HemaTrate Blood Filtration System can improve the condition of Critical Limb Ischemia (CLI). CLI is caused by severe blockage of blood flow to one or both legs, and patients may have symptoms such as pain at rest, wounds, and/or gangrene. Patients eligible for this study are not good candidates for the standard CLI treatments (for example, based on medical history), or previous treatments have proven unsuccessful. For these patients and those with untreated CLI, disease progression can lead to amputation of the affected leg.
The HemaTrate System is used to prepare a solution of cells from a patient’s own blood. Briefly, blood passes through the HemaTrate System’s filter, which captures white blood cells. The filter is then flushed with saline to obtain a concentrated solution of white blood cells called Total Nucleated Cells (TNCs). In this study, TNCs are injected near the area of a leg that does not have enough blood flow.
This study includes a group of patients receiving TNC injections and a group of patients receiving placebo (saline) injections. After 12 months - or earlier if a study doctor determines the study treatment has not worked - a study doctor will discuss the option of receiving TNC injections regardless of the patient’s starting group. The study will include up to 350 patients, and each patient’s participation is expected to last 2 years. Patients will undergo 6 office visits, including 3 visits where TNCs are injected. Additionally, there is one scheduled telephone call. After the final visit is completed - or if a patient exits the study for a different reason - no more patient information will be collected.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1970
Date of REC Opinion
21 Jan 2019
REC opinion
Further Information Favourable Opinion