Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
Study Details
Study Description
Brief Summary
Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
In an attempt to explore the contribution of Adipose Derived Stem Cells (ASCs) to chronic wound healing, we will investigate the effects of injecting ASCs into the periphery and debrided surfaces of chronic wounds. Our goal is to achieve healing in two months, and for the wounds to stay healed for the following two weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment of Chronic Wound Patients will receive a single treatment with ASCs in the form of multiple injections of cells within and immediately surrounding the wound. Cells will be delivered using a 1 cc syringe with an appropriate gauge and length needle. Each injection will have a volume less than 250 micro-liters. The number of injections will be determined by the surgeon as a function of total wound volume. |
Drug: Adipose derived stem cells
ASCs harvested from autologous lipoaspirate
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent change in wound size from baseline at 12 weeks [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female or male patient aged ≥ 18
-
With diagnosis of diabetic or other chronic wound
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Grade 1 or 2 wound on the Wagner Scale
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Ulcer with a surface area comprised greater than 4 cm2 included (after mechanical debridement of the ulcer)
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For subjects with more than one wound that meet these criteria, all qualifying wounds may be treated
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Patient's wound has been refractory to standard of care (no measureable signs of healing for at least 30 days)
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Patient has adequate (>200cc) abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest
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Patient has activated platelet thromboplastin time (aPTT) of < 1.6x the mean normal reference interval at the time of the lipoharvest procedure and no contraindication to lipoharvest
Exclusion Criteria:
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Typical Charcot's foot
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Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound [bone erosion or disappearance of the cortical bone]) as determined by MRI
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Clinical evidence of uncontrolled infection at the inclusion visit
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Patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue
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Subjects with cancerous or pre-cancerous lesions in the area to be treated
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Patient with working activity who cannot be on sick-leave during the study period
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Patient suffering from a psychiatric disorder not treated
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Clinical evidence of gangrene on any part of the affected foot
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Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment
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Pregnant or nursing females
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Patient receiving dialysis for renal insufficiency or who have severe renal dysfunction
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Patient who cannot have an off-loading method
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Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this study
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Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tower Outpatient Surgical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Tower Outpatient Surgical Center
Investigators
- Principal Investigator: Joel A. Aronowitz, M.D., Tower Multispecialty Medical Group
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Damour O, Gueugniaud PY, Berthin-Maghit M, Rousselle P, Berthod F, Sahuc F, Collombel C. A dermal substrate made of collagen--GAG--chitosan for deep burn coverage: first clinical uses. Clin Mater. 1994;15(4):273-6.
- Hanft JR, Surprenant MS. Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis. J Foot Ankle Surg. 2002 Sep-Oct;41(5):291-9.
- King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31.
- Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003 Jun;26(6):1701-5.
- Reiber GE, Vileikyte L, Boyko EJ, del Aguila M, Smith DG, Lavery LA, Boulton AJ. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999 Jan;22(1):157-62.
- Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13 Suppl 1:S6-11. Review.
- Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7.
- Williams R, Van Gaal L, Lucioni C; CODE-2 Advisory Board. Assessing the impact of complications on the costs of Type II diabetes. Diabetologia. 2002 Jul;45(7):S13-7. Epub 2002 Jun 12.
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