Stromal vascular fraction cells for the treatment of critical limb ischemia

• Register: ISRCTN
• Last refreshed on: 3 March 2020
• Main ID: ISRCTN13001382
• Date of registration: 26/04/2017
• Prospective Registration: No
• Primary sponsor: JSC Froceth
• Public title: Stromal vascular fraction cells for the treatment of critical limb ischemia
• Scientific title: Stromal vascular fraction cells for the treatment of critical limb ischemia
• Date of first enrolment: 01/02/2015
• Target sample size: 15
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13001382
• Study type: Interventional
• Study design: Interventional non-randomised study (Treatment)
• Phase: Not Specified

Countries of recruitment

Lithuania

Contacts

• Name: Adas Darinskas

Key inclusion & exclusion criteria

Inclusion criteria:
1. Smokers
2. Diabetic feet
3. Poor vascularisation of the limb
4. Prescribed amputation
5. Aged 18 years and over

Exclusion criteria:
1. Pregnancy
2. Age below 21


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Critical limb ischemia
Circulatory System
Critical limb ischemia

Intervention(s)

All participants undergo lipoaspiration in the hospital by plastic surgeon. This involves up to 200ml of lipoaspirate being collected so that stem cells can be isolated in the GMP qualified laboratory and registered into national stem cell tissue bank registry. Patients then undergo multiple stem cell injections into the problematic limb.

Every 24 hours following the injections, patients are regularly asked to rate their pain levels. In addition, at baseline and then after two weeks and two, six, 12 and 24 months, patients undergo an anghiography and complete a walking test to assess claudication.

Primary Outcome(s)

Pain is measured using the visual analogue scale (VAS) at baseline, 24, 48 and 72 hours post multiple injections.

Secondary Outcome(s)

1. Neovascularisation process is measured using angiography at baseline, 2 weeks, 2, 6, 12 and 24 months
2. Claudication index is assessed using a functional distance measurement test at baseline, 2 weeks, 2, 6, 12 and 24 months respectively

Secondary ID(s)

SOP2014FRCH10SVF001CLI

Source(s) of Monetary Support

JSC Froceth

Ethics review

Status:
Approval date:
Contact:

Due to Lithuanian law, for non manipulated autologous tissues we do not need ethics approvals as it is completely legal to perform these procedures for critical diseases and conditions based on medical procedure description. The law which legalises these applications of autologous cells is approved by Lithuanian Ministry of Health, 2014 December 2nd, the number of the document is V-1248. All procedures and protocols are introduced into the mentioned hospital (we have performed treatments) and al

Results

• Results available: Yes
• Date Completed: 01/01/2018