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

Pressure Ulcer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02375802
• Other study ID #: 14-002855
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: July 2015
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Males and females

• Stage III pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with Normal Saline).

• Inpatient or outpatient treatment of pressure ulcers

• Diabetic Foot Ulcer Stage 1 or 2 of any size

• Co-morbidities may include:

• Peripheral Vascular Disease (PVD)

• Coronary Artery Disease (CAD)

• Chronic Renal Disease (CRD)

• Chronic Liver Disease (CLD)

• Hypertension (HTN)

• Diabetes

• The ability of subjects to give appropriate consent or have an appropriate representative available to do so

• The ability of subjects to return for weekly wound assessments

Exclusion Criteria

• Patients with allergies to TISSEEL, Tegaderm, or silicon

• Diabetics with poor glucose metabolic control (HbA1c > 9)

• Target wounds that are in close proximity to potential cancerous lesions

• Patients who require Negative Pressure Wound Therapy (NPWT), limb amputation, or surgical intervention at the target wound at the time of screening

• Wounds located on the face

• Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers)

• Wounds caused by diabetes mellitus (diabetic foot ulcers).

• BMI of <16 Clinical signs of critical colonization or local infection

• Prolonged (> 6 months) use of steroids

• Patients on active regimen of chemotherapy

• Patients receiving radiation in proximity of wound

• Decompensated chronic liver disease

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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.

Drug:
• Adipose-derived stromal cells

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (13)

Akita S, Yoshimoto H, Akino K, Ohtsuru A, Hayashida K, Hirano A, Suzuki K, Yamashita S. Early experiences with stem cells in treating chronic wounds. Clin Plast Surg. 2012 Jul;39(3):281-92. doi: 10.1016/j.cps.2012.04.005. Epub 2012 May 22. — View Citation

Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy. 2013 Jun;15(6):641-8. doi: 10.1016/j.jcyt.2013.02.006. Epub 2013 Apr 6. — View Citation

Bura A, Planat-Benard V, Bourin P, Silvestre JS, Gross F, Grolleau JL, Saint-Lebese B, Peyrafitte JA, Fleury S, Gadelorge M, Taurand M, Dupuis-Coronas S, Leobon B, Casteilla L. Phase I trial: the use of autologous cultured adipose-derived stroma/stem cells to treat patients with non-revascularizable critical limb ischemia. Cytotherapy. 2014 Feb;16(2):245-57. doi: 10.1016/j.jcyt.2013.11.011. — View Citation

Cherubino M, Rubin JP, Miljkovic N, Kelmendi-Doko A, Marra KG. Adipose-derived stem cells for wound healing applications. Ann Plast Surg. 2011 Feb;66(2):210-5. doi: 10.1097/SAP.0b013e3181e6d06c. — View Citation

Falanga V, Iwamoto S, Chartier M, Yufit T, Butmarc J, Kouttab N, Shrayer D, Carson P. Autologous bone marrow-derived cultured mesenchymal stem cells delivered in a fibrin spray accelerate healing in murine and human cutaneous wounds. Tissue Eng. 2007 Jun;13(6):1299-312. doi: 10.1089/ten.2006.0278. — View Citation

Gorecki C, Brown JM, Nelson EA, Briggs M, Schoonhoven L, Dealey C, Defloor T, Nixon J; European Quality of Life Pressure Ulcer Project group. Impact of pressure ulcers on quality of life in older patients: a systematic review. J Am Geriatr Soc. 2009 Jul;57(7):1175-83. doi: 10.1111/j.1532-5415.2009.02307.x. Epub 2009 May 21. — View Citation

Graves N, Birrell F, Whitby M. Effect of pressure ulcers on length of hospital stay. Infect Control Hosp Epidemiol. 2005 Mar;26(3):293-7. doi: 10.1086/502542. — View Citation

Kim I, Lee SK, Yoon JI, Kim DE, Kim M, Ha H. Fibrin glue improves the therapeutic effect of MSCs by sustaining survival and paracrine function. Tissue Eng Part A. 2013 Nov;19(21-22):2373-81. doi: 10.1089/ten.TEA.2012.0665. Epub 2013 Jul 16. — View Citation

Lu D, Chen B, Liang Z, Deng W, Jiang Y, Li S, Xu J, Wu Q, Zhang Z, Xie B, Chen S. Comparison of bone marrow mesenchymal stem cells with bone marrow-derived mononuclear cells for treatment of diabetic critical limb ischemia and foot ulcer: a double-blind, randomized, controlled trial. Diabetes Res Clin Pract. 2011 Apr;92(1):26-36. doi: 10.1016/j.diabres.2010.12.010. Epub 2011 Jan 8. — View Citation

Rigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71. — View Citation

Sarasua JG, Lopez SP, Viejo MA, Basterrechea MP, Rodriguez AF, Gutierrez AF, Gala JG, Menendez YM, Augusto DE, Arias AP, Hernandez JO. Treatment of pressure ulcers with autologous bone marrow nuclear cells in patients with spinal cord injury. J Spinal Cord Med. 2011;34(3):301-7. doi: 10.1179/2045772311Y.0000000010. — View Citation

Teraa M, Sprengers RW, van der Graaf Y, Peters CE, Moll FL, Verhaar MC. Autologous bone marrow-derived cell therapy in patients with critical limb ischemia: a meta-analysis of randomized controlled clinical trials. Ann Surg. 2013 Dec;258(6):922-9. doi: 10.1097/SLA.0b013e3182854cf1. — View Citation

Zimmerlin L, Rubin JP, Pfeifer ME, Moore LR, Donnenberg VS, Donnenberg AD. Human adipose stromal vascular cell delivery in a fibrin spray. Cytotherapy. 2013 Jan;15(1):102-8. doi: 10.1016/j.jcyt.2012.10.009. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free of wound infection	Symptoms include fever along with new or increasing pain, erythema, local warmth, swelling, purulent discharge, and/or malodor	one week
Secondary	Liposuction procedure without complication	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.	one week
Secondary	Improved wound healing	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	weekly observation for 6 weeks

External Links

•   Mayo Clinic Clinical Trials