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Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia

NCT02864654 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-08-12

No results posted yet for this study

Summary

Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control.

Conditions

  • Critical Limb Ischemia
  • Arteriosclerosis Obliterans
  • Peripheral Arterial Disease
  • Thromboangiitis Obliterans
  • Diabetic Angiopathies

Interventions

PROCEDURE

ADRC injection

10 mL of autologous ADRC suspension will be injected intramuscularly

OTHER

ADRC isolation

ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10 ml of normal saline.

PROCEDURE

Liposuction

Sponsors & Collaborators

  • Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

    lead OTHER_GOV

Principal Investigators

  • Andrey A Kalinin, MD, PhD · Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

  • Andrey A Pulin, MD, PhD · Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

  • Evgeny R Lysenko, MD, PhD, Prof · FSBI Federal Clinial Center of Advanced medical Technologies FMBA of Russia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-08-31
Completion
2018-07-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864654 on ClinicalTrials.gov