Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02092870
Recruitment Status : Unknown
Verified March 2014 by Tower Outpatient Surgical Center.
Recruitment status was:  Recruiting
First Posted : March 20, 2014
Last Update Posted : March 20, 2014
Information provided by (Responsible Party):
Tower Outpatient Surgical Center

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Venous Ulcer Pressure Ulcer Drug: Adipose derived stem cells 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

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:
  • stem cells
  • stromal vascular fraction

Primary Outcome Measures :
  1. Percent change in wound size from baseline at 12 weeks [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02092870

Contact: Cloe S. Hakakian, B.S. 3106590705
Contact: Gali Barak, B.S. 3106590705

United States, California
Tower Outpatient Surgical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Cloe S. Hakakian, B.S.    310-659-0705   
Principal Investigator: Joel A. Aronowitz, M.D.         
Sponsors and Collaborators
Tower Outpatient Surgical Center
Principal Investigator: Joel A. Aronowitz, M.D. Tower Multispecialty Medical Group

Additional Information:

Responsible Party: Tower Outpatient Surgical Center Identifier: NCT02092870     History of Changes
Other Study ID Numbers: 001
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Tower Outpatient Surgical Center:
Chronic Wounds
Adipose Derived Stem Cells
Diabetic Foot

Additional relevant MeSH terms:
Diabetic Foot
Pressure Ulcer
Varicose Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Varicose Veins