The Effect of Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin

Официальное название

The Effect of Intradermal Stromal Vascular Fraction Transplantation on the Regeneration of Expanded Skin: a Randomized Controlled Trial

Обзор

This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

Подробное описание

This study is a randomized controlled trial aimed at evaluating the effect of intradermal stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. This study will enroll patients experiencing dermal exhaustion during the process of skin soft tissue expansion. Participants will be randomly assigned in a 1:1 ratio to either the stromal vascular fraction (SVF) transplantation group or the normal saline control group. To confirm eligibility, all potential participants will undergo a baseline screening visit. Those meeting the inclusion criteria will proceed to the study center for enrollment assessment, followed by randomization. Participants in the SVF transplantation group will undergo abdominal liposuction and receive intradermal SVF transplantation. Participants in the control group will receive intradermal injections of an equivalent volume of normal saline. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography.

Вмешательства

• Биопрепарат Stromal vascular fraction transplantation
  Subcutaneous fat was harvested from either the abdomen or the posterior inner thigh region and then digested with 600 U of collagenase (Shanghai Qiaoyuan Biological Pharmaceutical Co., Ltd, Shanghai, China) at 37°C and 150rpm for three hours. After enzymatic digestion, the lower aqueous phase liquid was aspirated to acquire the stromal vascular fraction (SVF). The SVF cell-pellet was washed and adjusted to 2×10\^6 cells/mL. Lidocaine cream will be applied to the expanded skin to achieve surface
• Биопрепарат Normal saline injection
  Lidocaine cream will be applied to the expanded skin to achieve surface anesthesia. The skin was marked with methylene blue and a total of 0.5ml 0.9% normal saline were transplanted intradermally at the center of each 2cm×2cm squares. The expander was inflated two times a week using constant pressure inflation method, where the intracapsular pressure was monitored using a pressure meter and the inflation was halted when the pressure reached 100 mmHg.

Первичные конечные точки

• Dermal thickness [Срок оценки: Baseline, 4 and 8 weeks after intervention]

Вторичные конечные точки (1)

• Skin surface area [Срок оценки: baseline, 4 and 8 weeks after intervention]

Критерии участия

Критерии включения

• Age: over 18 years and under 65 years;
• show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis;
• Have signed the informed consent form, agree to participate in this study, and are able to comply with follow-up requirements.

Критерии исключения

• Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
• Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
• Patients allergic to iodine or iodine-containing preparations;
• Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
• Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
• Patients with severely loose skin or insufficient subcutaneous fat tissue;
• Patients who request to withdraw informed consent and exit the clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07114692 · Shanghai9th-SVF-ES-RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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