Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

NCT02092870 | Completed Phase 2 DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.

Conditions

Diabetic Foot; Venous Ulcer; Pressure Ulcer

Keywords

Chronic Wounds; Diabetes; Adipose Derived Stem Cells; Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Percent change in wound size from baseline at 12 weeks

  12 weeks

Study Arms (1)

Treatment of Chronic Wound

EXPERIMENTAL

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

Interventions

Adipose derived stem cells DRUG

ASCs harvested from autologous lipoaspirate

Also known as: stem cells, stromal vascular fraction

Treatment of Chronic Wound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patient aged ≥ 18
• 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

You may not qualify if:

• Typical Charcot's foot
• 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

Sponsors & Collaborators

• Tower Outpatient Surgical Center: lead

Study Sites (1)

Tower Outpatient Surgical Center

Los Angeles, California, 90048, United States

Location

Related Publications (8)

• 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.

  PMID: 9727886 BACKGROUND

• 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.

  PMID: 12136406 BACKGROUND

• Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13 Suppl 1:S6-11. No abstract available.

  PMID: 8741821 BACKGROUND

• 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.

  PMID: 10333919 BACKGROUND

• 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.

  PMID: 12400712 BACKGROUND

• 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.

  PMID: 12766097 BACKGROUND

• 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.

  PMID: 9589248 BACKGROUND

• 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.

  PMID: 10147171 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joel A. Aronowitz, M.D.

  Tower Multispecialty Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 9, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

US (1)