Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02375802|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Biological: Adipose-derived stromal cells Drug: Adipose-derived stromal cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Liposuction will be done to extract 50-100 cc of adipose tissue which will be processed to obtain the stromal cells. The adipose-derived stromal cells will be injected into a fibrin sealant applicator and applied to the wound (intervention), Patients will receive 5.0x106 ASCs per cubic centimeter of wound area. The wound will be dressed with an occlusive dressing and soft silicone dressing. The dressing will remain in place for one week (minimally, 3 days). Follow-up will occur weekly for 6 weeks.
Biological: Adipose-derived stromal cells
Adipose-derived stromal cells contain stem cells which have been successful in enhancing wound healing. The product used as the carrier is a fibrin sealant called TISSEEL. Pre-pilot testing was done to verify viability of the stromal cells for up to 72 hours in the fibrin sealant.
Other Name: ASC's
Drug: Adipose-derived stromal cells
- Free of wound infection [ Time Frame: one week ]Symptoms include fever along with new or increasing pain, erythema, local warmth, swelling, purulent discharge, and/or malodor
- Liposuction procedure without complication [ Time Frame: one week ]Signs of adverse reactions to the liposuction procedure include an allergy to the Hunstad solution, infection at the puncture wound site or risk of bleeding at the puncture wound site. Risks include bleeding or infection at the site and bruising for approximately one week. No adverse consequences of fluid overload have been associated with low volume liposuction.
- Improved wound healing [ Time Frame: weekly observation for 6 weeks ]Wound healing is greater than 20% healing within two weeks documented by measurement of the wound bed or wound healing to less than the dermal layer documented by photography and agreement of healing between research nurse and wound physician consultant. Would not expect deterioration to a more severe level of tissue injury
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375802
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Houssam Farres, MD||Mayo Clinic|