Condition category
Circulatory System
Date applied
13/04/2017
Date assigned
26/04/2017
Last edited
22/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a long-term condition is a long term condition where a person is unable to control their blood sugar (glucose) levels. Over time, high blood sugar levels can damage the arteries, affecting blood flow. If a sufferer also smokes, a fatty substance called plaque builds up inside the arteries, further cutting off blood supply. As the arteries become narrower, patients begin the feel pain even when at rest and are at severe risk of developing ulcers or gangrene (critical limb ischaemia), which in severe cases can lead to amputation. Research has shown that the use of stem cells can improve circulation and help deliver oxygen to the body’s tissues but encouraging growth of new blood vessels, preventing the need or amputation. The aim of this study is to investigate the effectiveness of injecting patients with stem cells derived from their own fat tissue to treat CLI.

Who can participate?
Adult smokers with diabetic foot that is scheduled to be amputated

What does the study involve?
Participants undergo a liposuction procedure in order to collect up to 200ml of fat. This is then used to isolate stem cells in the laboratory. Participants then attend a study visit during which the stem cells are injected into the problematic limb. Following the injections, patients are regularly asked to rate their pain levels. At the start of the study and then after two weeks and two, six, 12 and 24 months, patients have a scan to find out whether any new blood vessels have formed and complete a walking test to find out if the symptoms of the CLI have improved and they are able to walk further.

What are the possible benefits and risks of participating?
Participants may benefit from receiving the stem cell treatment but this is not guaranteed. There is a small risk of pain following fat collection and stem cell injections.

Where is the study run from?
Vilnius City Clinical Hospital (Lithuania)

When is the study starting and how long is it expected to run for?
January 2015 to January 2018

Who is funding the study?
JSC Froceth (Lithuania)

Who is the main contact?
Mr Adas Darinskas
adas@froceth.lt

Trial website

Contact information

Type

Scientific

Primary contact

Mr Adas Darinskas

ORCID ID

http://orcid.org/0000-0002-1916-7535

Contact details

JSC Froceth
Linkmenu 28
Vilnius
LT-10104
Lithuania
+370 (0)61 608 734
adas@froceth.lt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SOP2014FRCH10SVF001CLI

Study information

Scientific title

Stromal vascular fraction cells for the treatment of critical limb ischemia

Acronym

SVF for CLI

Study hypothesis

Stromal vascular fraction cells are able to induce novel neovascularisation of lost vessels by arteriosclerosis and ischemia process.

Ethics approval

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 all the legal issues are completely solved

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Critical limb ischemia

Intervention

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.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2015

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. Pregnancy
2. Age below 21

Recruitment start date

01/02/2015

Recruitment end date

01/06/2015

Locations

Countries of recruitment

Lithuania

Trial participating centre

Vilnius City Clinical Hospital
Antakalnio str. 57, Vilnius, Lithuania
Vilnius
LT-10104
Lithuania

Sponsor information

Organisation

JSC Froceth

Sponsor details

Linkmenu 28
Vilnius
LT-08217
Lithuania
+370 (0)61 608 734
info@froceth.lt

Sponsor type

Charity

Website

http://www.audiniubankas.lt

Funders

Funder type

Charity

Funder name

JSC Froceth

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in the Journal of Translational Medicine.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Agne Vaitkeviciene (agne@froceth.lt)

Intention to publish date

13/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28629476

Publication citations

Additional files

Editorial Notes

22/06/2017: Publication reference added.