Adipose-derived Stem Cells to Treat Chronic Wounds.

March 21, 2023 updated by: Winthrop University Hospital

Use of Autologous Adipose-derived Stem Cell to Treat Chronic Wounds

The goal of this study is to determine whether autologous, adipose-derived regenerative cells improve the healing of chronic wounds. Ten patients will undergo fat harvest and peri-wound injection of the isolated cells in addition to the standard of care for the treatment of their chronic wound. Wound healing will be followed over 24 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be an open-label, preliminary, proof-of-concept trial. Ten patients will undergo debridement of their wound per the standard of care currently offered by Winthrop University Hospital along with concurrent fat harvest according to the standard protocols of the Winthrop University Hospital Plastic surgeons. The harvested fat will be immediately processed using an automated system to isolate regenerative cells, including stem cells. This will be followed by same-day subcutaneous injection of the isolated cells into the debrided wound site. The patients will then undergo weekly wound debridements according to the current standard of care treatment protocols. They will be followed weekly for 24 weeks in the outpatient wound clinic and observed for pain, erythema of the injection site, wound infection, edema, fever, bleeding and wound healing as measured by wound size and area. Fat harvest and subcutaneous injection will be repeated 3 months after the initial procedure if the wound has not decreased in size by at least 40%. Patients can undergo a maximum of 2 cycles of fat harvest and cell injection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must agree to adhere to all protocol procedures and return for weekly scheduled wound assessment visits, including requirements for taking and abstaining from medications.
  2. Subject is willing and able to read, understand and sign a written Informed Consent to participate in the study or have an appropriate representative available to do so.
  3. Subject must have a full thickness Stage III or Stage IV pressure ulcer, deep venous ulcer, deep diabetic ulcer, ischemic ulcer, abdominal wound, nonhealing surgical site or sickle cell ulcer. For subjects with more than one wound that meet these criteria, the largest qualifying wound will be treated.
  4. Subject has adequate (>200 mL) abdominal or other subcutaneous adipose tissue accessible by syringe-based fat harvest and is able to undergo a fat harvest procedure in the opinion of the investigator or per facility guidelines and has activated platelet thromboplastin time (aPTT) within the normal reference range at the time of the fat harvest procedure and no contraindication to fat harvest.
  5. Subject's wound has been refractory to standard of care (no objective/measureable signs of healing) for at least 30 days.

Exclusion Criteria:

  1. Subject has local infection with erythema > 2 cm, or involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis), or associated with local wound complications such as prosthetic materials or protruding surgical hardware.

  2. Subject has ≥ 2 of the following signs of systemic inflammatory response syndrome (SIRS) or septic shock within 7 days of screening:

    • Temperature > 38°C or < 36°C
    • Heart rate > 90 beats/min
    • Respiratory rate > 20 breaths/min or PaCO2 < 32 mm Hg
    • White blood cell count > 12,000 or < 4,000 cells/μL or ≥ 10% immature (band) forms.
  3. Subject has received biologic or cell therapy within 12 weeks of initiation of the study.
  4. Subject not eligible for syringe-based liposuction of at least 200 mL of subcutaneous adipose tissue, including therapeutic anticoagulation with INR >1.7 or PTT >60, or receiving GIIb/IIIa inhibitors within 2 weeks prior to the study.
  5. Subject has squamous cell carcinoma, basal cell carcinoma, melanoma or skin carcinoma of the affected limb or area and underwent treatment within the last year.
  6. Subject is pregnant as determined by a positive pregnancy test prior to procedure, or breast-feeding.
  7. Clinically significant abnormal findings on laboratory screening panels, including hemoglobin ≤10 g/dL.
  8. Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotranferase (ALT), or bilirubin level > 1.5 times the upper limit of normal range (x ULN) prior to randomization.
  9. Chronic renal insufficiency as defined as a serum creatinine > 2.0 mg/dL or requires dialysis.
  10. History of organ transplantation.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Patients will undergo a fat harvest procedure and the tissue will then be processed by The Celution System to isolate a 5 mL aliquot including stem cells. This will then be injected into the base and within in perimeter of the target wound.
Device: The Celution System
The Celution System will isolate regenerative cells, including stem cells, from fat harvested from the treatment patients.
Other Names:
  • Celution, Adipose-derived cell processor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety as assessed by weekly evalutation of the occurrence of wound infection, redness, swelling, pain, fever, chills, bleeding, and wound healing.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete wound healing
Time Frame: 1 year
Wounds will be evaluated for 100% epithelialization with no drainage.
1 year
Time to healing
Time Frame: 1 year
The time when complete healing occurs will be recorded, up to 1 year.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Winthrop University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cytori Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harold Brem, MD, Winthrop University Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15586

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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