Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine.Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’.Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with no-option critical limb ischemia (N-O CLI). - CardioCell evaluation in N-O CLI

Krakowski Szpital Specjalistyczny im. Jana Pawla II0 个研究点目标入组 115 人开始时间: 2018年1月22日最近更新: 2022年3月2日

试验速览

暂无简介。

•- Patients able to walk
•- Male and female patients, aged 18-80 years
•- No-option CLI (definition: exhausted revascularization options including surgery or endovascular treatment) in Rutherford stage 4-5
•- In case of bilateral N-O CLI, the limb with shorter claudication distance will be treated
•- Presence of adequate inflow (patent iliac and common femoral arteries)
•- Run-off through at least one (even partially seen) below-the-knee (BTK) artery
•- Signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 115
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 115

•- Malignancy
•- Moderate or severe immunodeficiency
•- Acute or chronic bacterial or viral infectious disease
•- Soft tissue disease or local infection in a place of required artery puncture
•- Pregnancy or breastfeeding
•- Any objective or subjective reason for inability to attend follow-up visits
•- Females of childbearing potential, who does not want to use a highly effective method of contraception
•- Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
•- Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this project
•- Life expectancy < 1 year
•- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project

发起方

Krakowski Szpital Specjalistyczny im. Jana Pawla II