Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy

NCT02961699 | Unknown DMC FDA Device

• 1 other identifier: CVSWH-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound, Nonpenetrating

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in wound area over time (wound healing velocity)

  enrollment through 12 months of follow-up

• Percent decrease in wound size (length X width X depth)

  enrollment through 12 months of follow-up

• Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life

  enrollment through 12 months of follow-up

• Assessment of overall health status (questionnaire 36-Item Short Form/SF-36)

  enrollment through 12 months of follow-up

• assessment of disease specific quality of life (questionnaire: CIVIQ-20)

  enrollment through 12 months of follow-up

Study Arms (2)

Transpose ® RT System

EXPERIMENTAL

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

debridement/dressing of wound

ACTIVE COMPARATOR

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

Interventions

Transpose ® RT System DEVICE

adipose-derived stem cell therapy

Transpose ® RT System

debridement/dressing of wound OTHER

standard of care debridement and wound dressing

debridement/dressing of wound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InGeneron, Inc.: lead

Study Sites (1)

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Wounds, Nonpenetrating

Interventions

Debridement; Bandages

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Equipment and Supplies

Study Officials

• Bradley K Coots, M.D.

  Sanford Plastic and Reconstructive Surgery- Sioux Falls, SD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: this study utilizes a medical device

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: June 1, 2017
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)