Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
Primary Purpose
Diabetic Foot, Venous Ulcer, Pressure Ulcer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adipose derived stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Chronic Wounds, Diabetes, Adipose Derived Stem Cells, Diabetic Foot
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Typical Charcot's foot
- 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
Sites / Locations
- Tower Outpatient Surgical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment of Chronic Wound
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent change in wound size from baseline at 12 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT02092870
First Posted
March 18, 2014
Last Updated
September 9, 2019
Sponsor
Tower Outpatient Surgical Center
1. Study Identification
Unique Protocol Identification Number
NCT02092870
Brief Title
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
Official Title
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tower Outpatient Surgical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Venous Ulcer, Pressure Ulcer
Keywords
Chronic Wounds, Diabetes, Adipose Derived Stem Cells, Diabetic Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment of Chronic Wound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Adipose derived stem cells
Other Intervention Name(s)
stem cells, stromal vascular fraction
Intervention Description
ASCs harvested from autologous lipoaspirate
Primary Outcome Measure Information:
Title
Percent change in wound size from baseline at 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Typical Charcot's foot
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel A. Aronowitz, M.D.
Organizational Affiliation
Tower Multispecialty Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tower Outpatient Surgical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9727886
Citation
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.
Results Reference
background
PubMed Identifier
12136406
Citation
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.
Results Reference
background
PubMed Identifier
8741821
Citation
Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13 Suppl 1:S6-11. No abstract available.
Results Reference
background
PubMed Identifier
10333919
Citation
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.
Results Reference
background
PubMed Identifier
12400712
Citation
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.
Results Reference
background
PubMed Identifier
12766097
Citation
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.
Results Reference
background
PubMed Identifier
9589248
Citation
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.
Results Reference
background
PubMed Identifier
10147171
Citation
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.
Results Reference
background
Links:
URL
http://www.emedicine.com/orthoped/topic387.htm
Description
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