Official Title

Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.
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 Started
Sep 30
Primary Completion
Sep 30
Study Completion
Sep 09
Last Update
Sep 11

Drug Adipose derived stem cells

ASCs harvested from autologous lipoaspirate

  • Other names: stem cells, stromal vascular fraction

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.


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
No Results Posted