Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02375802
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-13
First Post:
2015-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Pilot Study: Evaluating the Safety and Feasibility of Using Autologous Adipose-Derived Stromal Cells from Stromal Vascular Fraction (SVF) on Adults with Pressure Ulcers or Diabetic Foot Ulcers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: