Second- or Third-degree BurnsPhase 1/2ADSCs-BWsNCT03113747
Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs)
A Phase 1/2 study testing ALLO-ASCs in people with Second- or Third-degree Burns, run by A.A. Partners, LLC at 1 site in Ukraine.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Second- or Third-degree Burns
- What is being tested?
- ALLO-ASCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUkraine
- Study dates
- 25 Mar 2015to 26 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
The Kyiv City Clinical Hospital №2
Kyiv, 02094,13, Krakivska, str.,
Georgiy P. Kozynets, MD, PhD, DSc, +380973917611, dr.g.kozynets@gmail.com
Nataliia M. Olijnyk, PhD, +380904040116, N.Olijnyk@ilaya.ua
About this study
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
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
Read the 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.
- Conditions
- Second- or Third-degree Burns
- Being tested
- ALLO-ASCs
- Keywords
- Allogeneic adipose-derived stem cells, burn wounds, wound healing, regeneration, repair, skin tissue engineering
- Medical subject headings
- Neoplasm Metastasis, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-ASCsBiological
Also called Allogeneic adipose-derived stem cells
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: up to 1 month
Secondary outcomes (3)
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.
Measured: up to 1 month
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.
Measured: up to 1 month
Duration of treatment (days) to complete epithelialization of burn wounds;
Duration of treatment (days) to complete epithelialization of burn wounds;
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start25 Mar 2015
- Primary completion26 Dec 2018 (estimated)
- Study completion26 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Second- or Third-degree BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.A. Partners, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anatoliy V. Voronin, Principal investigator, The head doctor of The Kyiv City Clinical Hospital №2Georgiy P. Kozynets, MD, PhD, DSc, Principal investigator, Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113747
- Sponsor's protocol ID
- MSC-P1
- Acronym
- ADSCs-BWs
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22507764
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03113747
- Acronym / sponsor ID
- ADSCs-BWs / MSC-P1
- Conditions
- Second- or Third-degree Burns
- Keywords
- Allogeneic adipose-derived stem cells, burn wounds, wound healing, regeneration, repair, skin tissue engineering
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- A.A. Partners, LLCUniversity, hospital or other
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 26 Dec 2018 (estimated)
- Study completion
- 26 Dec 2018 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASCs | Experimental | Biological: ALLO-ASCsThe 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 |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLO-ASCsAlso: Allogeneic adipose-derived stem cells1). 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. | Biological | ALLO-ASCs |
Primary outcome
The degree of healing of skin flap; The degree of epithelialization of burn wounds in the perforations of a skin graft
Time frame: up to 1 month
The degree of healing of skin flap after autologous skin grafting;
3 secondary outcomes
The dynamics of healing of skin flap
Time frame: up to 1 month
Dynamics of the phagocytic activity of neutrophils in the area of burn wounds, according to NBT-test.
Time frame: up to 1 month
Duration of treatment (days) to complete epithelialization of burn wounds;
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 22507764Alexaki 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.
- Adipose tissue-derived mesenchymal cells support skin reepithelialization through secretion of KGF-1 and PDGF-BB: comparison with dermal fibroblasts.Link provided by the sponsor.
- 1\. \[10 years' experience of using cultured human skin cells for the treatment of thermal burns\]. \[Електронний ресурс\] // MedlinePlus Health Information/ \[Tumanov VP, Alekseev AA, Budkevich LI\]/ - 1999.Link provided by the sponsor.
- 2\. Allografting of cultured fibroblasts on nonhealing wounds after autodermoplasty. D. S. Sarkisov, E. V. Glushchenko, Sh. R. Gurukov, S. S. Morozov, V. P. Tumanov, N. V. Berezhkov Bulletin of Experimental Biology and Medicine/May 1991, Volume 111, IssueLink provided by the sponsor.
- 3\. Alekseev AA, Krutikov MG, Rakhaev AM/ Treatment of border burns and donor wounds with cultured allofibroblasts// Annals of Surgery. 2001. № 1. С. 59-65.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Second- or Third-degree Burns
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatoliy V. Voronin principal investigator
The head doctor of The Kyiv City Clinical Hospital №2
Georgiy P. Kozynets, MD, PhD, DSc principal investigator
Head of the department of combustiology and plastic surgery, Shupyk National Medical Academy of Postgraduate Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALLO-ASCs in people with Second- or Third-degree Burns, run by A.A. Partners, LLC at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volodymyr S. Melnyk, MD, DSc (+380679337461, V.Melnyk@ilaya.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of healing of skin flap; The degree of epithelialization of burn wounds in the perforations of a skin graft (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.