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Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)

NCT03113747 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-04-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety and efficacy of tissue engineered construct based on allogeneic cultured adipose-derived multipotent mesenchymal stromal cells (ALLO-ADSCs) and platelet-poor plasma fibrin hydrogel to treat patients with 2-B and 3- degree burn wounds

Conditions

  • Second- or Third-degree Burns

Interventions

BIOLOGICAL

ALLO-ASCs

1). Cryopreserved cell suspension of early passages of cultured allogeneic MSCs isolated from SVF obtained from lipoaspirate, a total of 10 mln. of cultured cells; 2).The TE-construct consisting of collagen- or fibrin-derived hydrogels and cells of early passages (up to P5) suspension of allogeneic cultured MSCs isolated from SVF obtained from lipoaspirate; Biological is applied by surface application over perforated (1:3) autologous skin graft following the covering with hypoadhesive bandage. This procedure is carried out twice - once simultaneously with a skin grafting procedure and 2-3 days following autodermoplasty, while bandaging.

Sponsors & Collaborators

  • A.A. Partners, LLC

    lead OTHER

Principal Investigators

  • Anatoliy V. Voronin · The head doctor of The Kyiv City Clinical Hospital №2

  • Georgiy P. Kozynets, MD, PhD, DSc · Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2018-12-26
Completion
2018-12-26

Countries

  • Ukraine

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 NCT03113747 on ClinicalTrials.gov