Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy

This is a prospective, randomized, single-site, safety and efficacy study of subjects with chronic venous stasis ulcers. Patients will fall into two categories: treatment arm (24 subjects) and non-treatment or control arm (12 subjects). The treatment group will undergo a small liposuction procedure and receive placement of autologous cell therapy (stromal vascular fraction or SVF) injected around the rim of venous stasis wound (subcutaneously)following standard wound debridement, with saturation of collagen dressing material with standard over-dressing. Control (non-treatment) subjects will receive debridement and dressing changes as per standard of care without SVF.

Study Overview

• Status: Unknown
• Conditions: Wound, Nonpenetrating
• Intervention / Treatment: Device: Transpose ® RT System; Other: debridement/dressing of wound

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford USD Medical Center

Participation Criteria

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:

• Males and females 18 years of age or older
• venous leg ulcers present for at least six months and not responding to
• standard wound therapy for at least one month prior to study treatment
• one wound size 10-25centimeters squared
• inpatient or outpatient treatment of chronic venous ulcers
• the ability of subjects to give appropriate consent or have an appropriate representative available

Exclusion Criteria:

• Age < 18 years of age
• Patients who are pregnant or currently breast feeding
• for a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 7 days prior to the procedure
• Patient with a BMI less than or equal to 18.5 or an insufficient amount of subcutaneous tissue to allow recovery of up to 100ml of lipoaspirate
• Patients with poor glucose metabolic control (HgbA1c > 9)
• history of local neoplasm and any history of local neoplasm and any history of local neoplasm at site of administration
• History of systemic malignant neoplasms within last 5 years
• Patients who require Negative Pressure Wound Therapy (NPWT) or limb amputation at the target wound at the time of screening
• Wounds which are unable to be staged or classified. For example, full thickness tissue loss in which actual depth of the ulcer is completely obscured by slough and/or eschar in the wound bed
• Wounds that have evidence of necrosis after debridement
• Severe vascular disease in the pathogenesis of the ulcer (ABI<0.6)
• Clinical signs of critical colonization or local infection
• Prolonged(>6 months) of use of steroids
• Patients on an active regimen of chemotherapy
• Patients who have received radiation in proximity of the wound
• Patients with a documented history of liver disease or an ALT value>400
• Allergy to sodium citrate of any "caine" type of local anesthetic
• Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of the Patient Reported Outcome instruments.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Subject is part of a vulnerable population who, in the judgement of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, person in nursing homes, children, impoverished persons, persons in emergency situations, homeless person, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transpose ® RT System; Adipose-derived stem cells (also known as stromal vascular fraction or SVF) will be injected subcutaneously around the rim of the wound bed following standard would debridement. The standard collagen dressing material will also be saturated with SVF after placement within the would itself. Normal (standard) dressing of wound will be placed over wound.	Device: Transpose ® RT System; adipose-derived stem cell therapy
Active Comparator: debridement/dressing of wound; Wound will be debrided and collagen dressing placed within wound bed as per standard of care. Standard dressing will cover wound. No adipose-derived stem cells (SVF) will be applied to control subject wounds.	Other: debridement/dressing of wound; standard of care debridement and wound dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: as indicated through adverse event rate between control versus experimental group	adverse event rate	enrollment through 12 months of follow-up
Time to complete wound closure as evidenced by complete epithelialization over a one-year time period (efficacy)	time it takes for complete wound closure following procedure	enrollment through 12 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound area over time (wound healing velocity)	size of wound will become smaller as measured during follow-up visits	enrollment through 12 months of follow-up
Percent decrease in wound size (length X width X depth)	wound size will decrease when measured at follow-up visits	enrollment through 12 months of follow-up
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life	patient will report better health outcomes using quality of life questionnaires	enrollment through 12 months of follow-up
Assessment of overall health status (questionnaire 36-Item Short Form/SF-36)	patient will report better health outcomes using quality of life questionnaires	enrollment through 12 months of follow-up
assessment of disease specific quality of life (questionnaire: CIVIQ-20)	quality of life as it relates to lower extremity wound will improve following treatment as noted in patient's CIVIQ-20 scores	enrollment through 12 months of follow-up

Collaborators and Investigators

• Sponsor: InGeneron, Inc.
• Investigators: Principal Investigator: Bradley K Coots, M.D., Sanford Plastic and Reconstructive Surgery- Sioux Falls, SD

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Wounds and Injuries; Varicose Ulcer; Wounds, Nonpenetrating
• Other Study ID Numbers: CVSWH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes