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

Primary Purpose

Second- or Third-degree Burns

Status
Unknown status
Phase
Phase 1
Locations
Ukraine
Study Type
Interventional
Intervention
ALLO-ASCs
Sponsored by
A.A. Partners, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Second- or Third-degree Burns focused on measuring Allogeneic adipose-derived stem cells, burn wounds, wound healing, regeneration, repair, skin tissue engineering

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • make the subject unsuitable to participate in this study or to complete it;
  • Participation in another clinical trial

Sites / Locations

  • The Kyiv City Clinical Hospital №2Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ALLO-ASCs

The standard treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

The dynamics of healing of skin flap
Complete epithelization or epithelization more than 50% of the cells in the skin graft on the 10th day after autologous skin grafting are effective. The epithelialization less than 50% is not effective.
Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.
Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.
Duration of treatment (days) to complete epithelialization of burn wounds;
Duration of treatment (days) to complete epithelialization of burn wounds;

Full Information

First Posted
March 31, 2017
Last Updated
April 25, 2017
Sponsor
A.A. Partners, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03113747
Brief Title
Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)
Acronym
ADSCs-BWs
Official Title
Safety and Efficacy Evaluation of Tissue Engineered Construct Based on Allogeneic Adipose-derived Multipotent Mesenchymal Stromal Cells and Platelet-poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2015 (Actual)
Primary Completion Date
December 26, 2018 (Anticipated)
Study Completion Date
December 26, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A.A. Partners, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
For more than 20 years in clinical practice allogeneic transplantation of diploid fibroblasts (ADP) for burn wounds has been successfully used, it is used as an independent method, and a method of preparing wounds for autologous skin grafting [1]. The clinical efficacy of transplantation ADP, after the research done by E.V. Glushchenko; Rahayev AM [2,3] is not doubted. Several studies have shown the efficacy of stem cells in promoting faster and superior wound healing. Alexaki [4] successfully used adipose derived mesenchymal stem cells in wound healing in mice and compared their effect with dermal fibroblasts. The application of stem cells in wounds promoted more efficient reepithelialization by their proliferative effect on keratinocytes. In recent years, the world's leading burn centers attempted to restore the skin over large areas of burn wounds by epidermal layers transplantation of allogeneic cells cultured in culture medium. The information expected in the study will be based on the principles of evidence-based medicine and will have practical significance for the treatment of burn wounds. It is expected to show a positive effect of cultured multipotent mesenchymal stromal cells in the epithelization of burn wounds process as well as the extent and speed healing of skin flap during autologous skin grafting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Second- or Third-degree Burns
Keywords
Allogeneic adipose-derived stem cells, burn wounds, wound healing, regeneration, repair, skin tissue engineering

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALLO-ASCs
Arm Type
Experimental
Arm Description
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
Arm Title
The standard treatment
Arm Type
No Intervention
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
ALLO-ASCs
Other Intervention Name(s)
Allogeneic adipose-derived stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
The degree of healing of skin flap; The degree of epithelialization of burn wounds in the perforations of a skin graft
Description
The degree of healing of skin flap after autologous skin grafting;
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
The dynamics of healing of skin flap
Description
Complete epithelization or epithelization more than 50% of the cells in the skin graft on the 10th day after autologous skin grafting are effective. The epithelialization less than 50% is not effective.
Time Frame
up to 1 month
Title
Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.
Description
Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.
Time Frame
up to 1 month
Title
Duration of treatment (days) to complete epithelialization of burn wounds;
Description
Duration of treatment (days) to complete epithelialization of burn wounds;
Time Frame
up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 make the subject unsuitable to participate in this study or to complete it; Participation in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Volodymyr S. Melnyk, MD, DSc
Phone
+380679337461
Email
V.Melnyk@ilaya.ua
First Name & Middle Initial & Last Name or Official Title & Degree
Nataliia M. Olijnyk, PhD
Phone
+380934040116
Email
N.Olijnyk@ilaya.ua
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anatoliy V. Voronin
Organizational Affiliation
The head doctor of The Kyiv City Clinical Hospital №2
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgiy P. Kozynets, MD, PhD, DSc
Organizational Affiliation
Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Kyiv City Clinical Hospital №2
City
Kyiv
ZIP/Postal Code
02094,13, Krakivska, str.,
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgiy P. Kozynets, MD, PhD, DSc
Phone
+380973917611
Email
dr.g.kozynets@gmail.com
First Name & Middle Initial & Last Name & Degree
Nataliia M. Olijnyk, PhD
Phone
+380904040116
Email
N.Olijnyk@ilaya.ua
First Name & Middle Initial & Last Name & Degree
Dmytro O. Zubov, PhD
First Name & Middle Initial & Last Name & Degree
Roman G. Vasyliev

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22507764
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/22507764
Description
Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts.
URL
https://www.ncbi.nlm.nih.gov/pubmed/22507764
Description
4. Alexaki V.-I. et al. Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts. Cell Transplantation. 2012;21(11):2441-2454.

Learn more about this trial

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

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