Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02375802
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Enrolling by invitation
Phase	Phase 1
Start date	July 2015
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03351049` - An RCT on Support Surfaces for Pressure Ulcer Prevention	N/A
Completed	`NCT05112068` - Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
Completed	`NCT05575869` - Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students	N/A
Completed	`NCT03220451` - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients	N/A
Recruiting	`NCT04540822` - Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care	N/A
Terminated	`NCT05234632` - Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds	N/A
Completed	`NCT02092870` - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds	Phase 2
Terminated	`NCT01966380` - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia	Phase 2
Completed	`NCT01438541` - A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration	Phase 4
Completed	`NCT00365430` - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes	N/A
Completed	`NCT04251897` - Novel Support Surface to Alleviate Pressure Ulcer	N/A
Completed	`NCT03391310` - Use of Honey for Pressure Ulcers in Critically Ill Children	N/A
Recruiting	`NCT04559165` - Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore	N/A
Completed	`NCT05646121` - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Terminated	`NCT05547191` - Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement	N/A
Completed	`NCT05458050` - An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers	N/A
Active, not recruiting	`NCT03048357` - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.	N/A
Completed	`NCT06025370` - Pressures During Prone Positions in Healthy Volunteers	N/A
Recruiting	`NCT05033470` - A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers	N/A
Terminated	`NCT04023981` - Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers	N/A