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Stromal vascular fraction cells for the treatment of critical limb ischemia

Stromal vascular fraction cells for the treatment of critical limb ischemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13001382
Enrollment
15
Registered
2017-04-26
Start date
2015-02-01
Completion date
Unknown
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical limb ischemia Circulatory System Critical limb ischemia

Interventions

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

Sponsors

JSC Froceth
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: 1. Pregnancy 2. Age below 21

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Lithuania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026