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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03113747
• Date of registration: 31/03/2017
• Prospective Registration: No
• Primary sponsor: A.A. Partners, LLC
• Public title: Allogeneic ADSCs and Platelet-Poor Plasma Fibrin Hydrogel to Treat the Patients With Burn Wounds (ADSCs-BWs) ADSCs-BWs
• Scientific 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
• Date of first enrolment: March 25, 2015
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03113747
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Ukraine

Contacts

• Name: Georgiy P. Kozynets, MD, PhD, DSc

• Name: Anatoliy V. Voronin
• Affiliation: The head doctor of The Kyiv City Clinical Hospital ?2

• Name: Volodymyr S. Melnyk, MD, DSc

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

Key inclusion & exclusion 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;

- Pregnan?y;

- 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Second- or Third-degree Burns

Intervention(s)

Biological: ALLO-ASCs

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

The dynamics of healing of skin flap [Time Frame: up to 1 month]

Secondary ID(s)

MSC-P1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors