Stromal vascular fraction cells for the treatment of critical limb ischemia
| ISRCTN | ISRCTN13001382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13001382 |
| Secondary identifying numbers | SOP2014FRCH10SVF001CLI |
- Submission date
- 13/04/2017
- Registration date
- 26/04/2017
- Last edited
- 21/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
JSC Froceth
Linkmenu 28
Vilnius
LT-10104
Lithuania
 ORCID ID |
0000-0002-1916-7535 |
|---|---|
| Phone | +370 (0)61 608 734 |
| adas@froceth.lt |
Study information
| Study design | Interventional non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Stromal vascular fraction cells for the treatment of critical limb ischemia |
| Study acronym | SVF for CLI |
| Study objectives | Stromal vascular fraction cells are able to induce novel neovascularisation of lost vessels by arteriosclerosis and ischemia process. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/01/2015 |
| Completion date | 01/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 |
| Key inclusion criteria | 1. Smokers 2. Diabetic feet 3. Poor vascularisation of the limb 4. Prescribed amputation 5. Aged 18 years and over |
| Key exclusion criteria | 1. Pregnancy 2. Age below 21 |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 01/06/2015 |
Locations
Countries of recruitment
- Lithuania
Study participating centre
Vilnius
LT-10104
Lithuania
Sponsor information
Charity
Linkmenu 28
Vilnius
LT-08217
Lithuania
| Phone | +370 (0)61 608 734 |
|---|---|
| info@froceth.lt | |
| Website | http://www.audiniubankas.lt |
"ROR" |
https://ror.org/04tgkyt11 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 13/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/06/2017 | Yes | No |
Editorial Notes
21/02/2020: The Lithuanian Bioethics Committee has investigated the published results article for this study and has concluded that the data in the article are unreliable. The journal article was retracted on 18/02/2020. Please see the retraction note https://doi.org/10.1186/s12967-017-1243-3 for more information.
22/06/2017: Publication reference added.
