MedTrace Logo

Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers

NCT05274295 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-05-03

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.

Conditions

  • Diabetic Foot Ulcer
  • Leg Ulcer
  • Autologous Adipose Stromal Vascular Fraction
  • Mesenchymal Stem Cells
  • Adipose-Derived Mesenchymal Stem Cells

Interventions

DEVICE

Diabetic leg ulcer treatment with adipous SVF

The Celution® System isolates approximately maximum 30 million SVF cells per 100 mL of adipose tissue to be processed. Approximately 1-3 million cells per injection (total 8-30) will be administered locally, in the target ulcer.

Sponsors & Collaborators

  • Szeged University

    lead OTHER

Principal Investigators

  • Balázs Bende, MD · Szeged University

  • Lajos Kemény, Prof. Dr. · Szeged University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Hungary

Study Locations

More Related Trials

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 NCT05274295 on ClinicalTrials.gov