Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

September 9, 2019 updated by: Tower Outpatient Surgical Center
Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Tower Outpatient Surgical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in wound size from baseline at 12 weeks
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tower Outpatient Surgical Center

Investigators

  • Principal Investigator: Joel A. Aronowitz, M.D., Tower Multispecialty Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 9, 2019

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (ESTIMATE)

March 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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