Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
NCT ID: NCT02092870
Last Updated: 2019-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2013-09-30
2019-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Adipose derived stem cells
ASCs harvested from autologous lipoaspirate
Interventions
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Adipose derived stem cells
ASCs harvested from autologous lipoaspirate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With diagnosis of diabetic or other chronic wound
* Grade 1 or 2 wound on the Wagner Scale
* Ulcer with a surface area comprised greater than 4 cm2 included (after mechanical debridement of the ulcer)
* For subjects with more than one wound that meet these criteria, all qualifying wounds may be treated
* Patient's wound has been refractory to standard of care (no measureable signs of healing for at least 30 days)
* Patient has adequate (\>200cc) abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest
* 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
* 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
* Clinical evidence of uncontrolled infection at the inclusion visit
* Patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue
* Subjects with cancerous or pre-cancerous lesions in the area to be treated
* Patient with working activity who cannot be on sick-leave during the study period
* Patient suffering from a psychiatric disorder not treated
* Clinical evidence of gangrene on any part of the affected foot
* 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
* Pregnant or nursing females
* Patient receiving dialysis for renal insufficiency or who have severe renal dysfunction
* Patient who cannot have an off-loading method
* 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
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
18 Years
ALL
No
Sponsors
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Tower Outpatient Surgical Center
OTHER
Responsible Party
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Principal Investigators
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Joel A. Aronowitz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Tower Multispecialty Medical Group
Locations
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Tower Outpatient Surgical Center
Los Angeles, California, United States
Countries
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References
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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. doi: 10.2337/diacare.21.9.1414.
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. doi: 10.1007/s00125-002-0859-9. Epub 2002 Jun 12.
Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13 Suppl 1:S6-11. No abstract available.
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. doi: 10.2337/diacare.22.1.157.
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. doi: 10.1016/s1067-2516(02)80047-3.
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. doi: 10.2337/diacare.26.6.1701.
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. doi: 10.2337/diacare.21.5.822.
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. doi: 10.1016/0267-6605(94)90057-4.
Related Links
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Related Info
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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