Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02375802
Brief Summary:
This pilot study of 12 patients will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III or IV pressure ulcer or diabetic foot ulcers. Patients will undergo a minimal risk liposuction procedure to withdraw 50-100 cc of adipose tissue. The tissue would be processed to extract the stromal layer of cells that contain stem cells. The ASCs would be injected into a fibrin sealant to be applied to the wound. Patients would be followed for 6 weeks to assess wound healing and tolerance of the treatment.
Detailed Description:
Wound healing for Stage III and IV pressure ulcers or diabetic foot ulcers can take four to six weeks or longer and cost upwards of $40,000 to treat. Past studies have shown that adipose tissue contains progenitor cells or regenerative cells that can release multiple angiogenic growth factors and cytokines including vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF) and chemokine stromal cell-derived factor-1 (SDF-1). A current literature review revealed that there is research related to use of stem cells to enhance wound healing, in particular with ischemic or radiation-induced ulcers. However, there is limited research completed on use of stem cells or ASCs with pressure ulcers. The goal is to heal pressure ulcers faster and prevent further complications using the patient's own natural ASCs.
Study:
NCT02375802
Study Brief:
Protocol Section:
NCT02375802