Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy

• ClinicalTrials.gov Identifier: NCT02961699
• Recruitment Status: Unknown
• First Posted: November 11, 2016
• Last Update Posted: July 28, 2020
• Sponsor: InGeneron, Inc.
• Information provided by (Responsible Party): InGeneron, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Wound, Nonpenetrating	Device: Transpose ® RT System; Other: debridement/dressing of wound	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: this study utilizes a medical device
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: January 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, South Dakota

Sanford USD Medical Center

Sioux Falls, South Dakota, United States, 57105

Sponsors and Collaborators

InGeneron, Inc.

Investigators

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

More Information

• Responsible Party: InGeneron, Inc.
• ClinicalTrials.gov Identifier: NCT02961699
• Other Study ID Numbers: CVSWH-001
• First Posted: November 11, 2016
• Last Update Posted: July 28, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Varicose Ulcer; Wounds and Injuries; Wounds, Nonpenetrating; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases