Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)

NCT02454231 | Completed Phase 2 DMC

• 1 other identifier: UFlorence
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators designed a randomized clinical trial (stem cell emergency life threatening arteriopathy or SCELTA) to compare the therapeutic efficacy of the auto-transplant of enriched circulating EPCs (ECEPCs) with auto-transplant of BM-MNCs. ECEPCs, obtained by immunoselection of CD14+ and CD34+ cells, or BM-MNCs, were injected intramuscularly in the affected limb of patients with critical limb ischemia (CLI).

Conditions

Critical Limb Ischemia

Keywords

EPC; CD34+; CD14+CD34low

Outcome Measures

Primary Outcomes (2)

• Safety as measured by evaluation of any adverse event temporary correlated with the treatment

  Evaluation of any adverse event temporary correlated with the treatment

  52 weeks of follow-up

• Changes in ischemic leg perfusion from baseline

  Improvement of leg perfusion as assessed by values of Time to Pick (TTP) evaluated by ultrasound tools

  4, 22, 52 weeks of follow-up

Secondary Outcomes (10)

• Improvement of Mean values of the transcutaneous partial oxygen pressure (TCP02)

  4, 22, 52 weeks of follow-up

• Improvement of mean values of ankle brachial pressure index (ABI)

  4, 22, 52 weeks of follow-up

• Improvement of vessel anatomical status

  4, 22, 52 weeks of follow-up

• Improvement of leg perfusion

  4, 22, 52 weeks of follow-up

• Improvement of vessel anatomical status

  4, 22, 52 weeks of follow-up

Study Arms (2)

peripheral blood EPC injection

EXPERIMENTAL

Biological: Transplantation of circulating CD14+CD34+cells

bone marrow MNC injection

ACTIVE COMPARATOR

Biological: Transplantation of BM MNC

Interventions

Transplantation of circulating CD14+CD34+cells BIOLOGICAL

intramuscular injection of circulating EPC at leg level

peripheral blood EPC injection

Transplantation of BM MNC BIOLOGICAL

intramuscular injection of BM MNC at leg level

bone marrow MNC injection

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients were men and women aged more than 40 years with a diagnosis of CLI due to atherosclerosis of the lower extremities, as defined by the presence of persistent rest pain requiring systemic and continued analgesic treatment in the last 15 days and/or the presence of trophic lesions imputable to the occluding arteriopathy, an ankle-brachial Index (ABI) \< 0.40 (with systolic ankle pressure \< 50-70 Hg mm), a toe/brachial index (TBI) \< 0.40 (with big toe systolic pressure \< 30-50 Hg mm), and a transcutaneous oxygen pressure (TC pO2) \< 30 Hg mm.
• The patient was considered as eligible for the treatment and enrolled only after the demonstration that intravascular or surgical re-vascularization was not possible, as revealed by ecography and angio-CAT, or when the patient refused to undergo surgical treatments and after having obtained his/her written informed consensus.

You may not qualify if:

• not atherosclerotic CLI,
• myocardial infarction occurrence in the 6 months;
• cardiac failure of III-IV class NYHA;
• ejection fraction lower than 40%;
• arterial hypertension (\>160/100 Hg mm) uncontrolled despite the usage of two anti-hypertensive drugs;
• presence of current or chronic severe infectious diseases;
• osteomyelitis;
• diabetes with glycate hemoglobin \> 7.5;
• proliferative diabetic retinopathy;
• hemorrhagic disorders;
• non-atherosclerotic arteriopathy;
• chronic airway insufficiency (p02 \<65 Hg mm, pCO2 \> 0.50 Hg mm);
• renal failure (creatinine \> 2mg/dl);
• contraindications or intolerance to contrast media for radiologic imaging

Sponsors & Collaborators

• University of Florence: lead
• Tuscany Region: collaborator

Study Sites (1)

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Related Publications (20)

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MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Enrico Maggi, professor

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Director of the Unit of Immunology and Cellular Therapy

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 27, 2015
• Study Start: September 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

IT (1)