NCT03113747

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

3.8 years

First QC Date

March 31, 2017

Last Update Submit

April 25, 2017

Conditions

Second- or Third-degree Burns

Keywords

Allogeneic adipose-derived stem cellsburn woundswound healingregenerationrepairskin tissue engineering

Outcome Measures

Primary Outcomes (1)

  • The degree of healing of skin flap; The degree of epithelialization of burn wounds in the perforations of a skin graft

    The degree of healing of skin flap after autologous skin grafting;

    up to 1 month

Secondary Outcomes (3)

  • The dynamics of healing of skin flap

    up to 1 month

  • Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.

    up to 1 month

  • Duration of treatment (days) to complete epithelialization of burn wounds;

    up to 1 month

Study Arms (2)

ALLO-ASCs

EXPERIMENTAL

The patients receive ALLO-ADSCs. 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

Biological: ALLO-ASCs

The standard treatment

NO INTERVENTION

All patients will be subjected to standard stepped treatment of burn wounds: * Infusion therapy aimed to eliminate disorders of homeostasis during burn shock and burn toxemia; * Systemic antibiotic therapy for preventing infectious complications; * Adequate analgesia and sedation; * Decompression necrotomy in the first 24 hours following the burn trauma; * Necrectomy simultaneously with imposition of lyophilized xenografts performed in the first 1-5 days after applying burn; * Autologous skin grafting 3-5 days after performed xenografts with the perforation coefficient 1:3

Interventions

ALLO-ASCsBIOLOGICAL

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.

Also known as: Allogeneic adipose-derived stem cells
ALLO-ASCs

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female aged 18-65 years;
  • Patients with 2-nd B and 3-d degree burn wound;
  • Body surface area involved in burns - from 10 to 50%;
  • The area of skin grafting - less than 6% of the skin surface;
  • Burn occurring within the 24 hours prior to the hospitalization;
  • Adequate antishock therapy in the prehospital phase;
  • Women of childbearing age to provide proof of a current, valid negative pregnancy test;
  • Confirmation of participation in the study by signing the Instrument of Consent, personally or through a responsible caretaker.

You may not qualify if:

  • Prognostically favorable or unfavorable outcome of the disease
  • (Lesion Severity Index, less than 30 or more, than 120 score);
  • Combined trauma;
  • Severe respiratory tract burn injuries;
  • Ischemic disease of the lower extremities;
  • The presence of cardiovascular disease (CVD): symptoms of unstable angina, myocarditis, heart disease, heart failure;
  • History of prior cancer;
  • Healing of duodenal or gastric ulcers in history;
  • Diabetes
  • Severe chronic liver diseases or kidney disease in history;
  • History of alcohol or other drug abuse;
  • Pregnanсy;
  • Any other physical diseases in decompensation or subcompensation,
  • or those that are rated as severe or moderate;
  • Therapeutic issues or psychiatric disorders of a patient which would
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Kyiv City Clinical Hospital №2

Kyiv, 02094,13, Krakivska, str.,, Ukraine

RECRUITING

Related Publications (1)

  • Alexaki VI, Simantiraki D, Panayiotopoulou M, Rasouli O, Venihaki M, Castana O, Alexakis D, Kampa M, Stathopoulos EN, Castanas E. Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts. Cell Transplant. 2012;21(11):2441-54. doi: 10.3727/096368912X637064. Epub 2012 Apr 10.

    PMID: 22507764BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisBurns

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Anatoliy V. Voronin

    The head doctor of The Kyiv City Clinical Hospital №2

    PRINCIPAL INVESTIGATOR

  • Georgiy P. Kozynets, MD, PhD, DSc

    Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Volodymyr S. Melnyk, MD, DSc

CONTACT

+380679337461V.Melnyk@ilaya.ua

Nataliia M. Olijnyk, PhD

CONTACT

+380934040116N.Olijnyk@ilaya.ua

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 14, 2017

Study Start

March 25, 2015

Primary Completion

December 26, 2018

Study Completion

December 26, 2018

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

UA(1)