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Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02961699
Recruitment Status : Active, not recruiting
First Posted : November 11, 2016
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
InGeneron, Inc.

Tracking Information
First Submitted Date  ICMJE November 9, 2016
First Posted Date  ICMJE November 11, 2016
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • Safety: as indicated through adverse event rate between control versus experimental group [ Time Frame: enrollment through 12 months of follow-up ]
    adverse event rate
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02961699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy
Official Title  ICMJE Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
this study utilizes a medical device
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wound, Nonpenetrating
Intervention  ICMJE
  • Device: Transpose ® RT System
    adipose-derived stem cell therapy
  • Other: debridement/dressing of wound
    standard of care debridement and wound dressing
Study Arms  ICMJE
  • 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.
    Intervention: Device: Transpose ® RT System
  • 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.
    Intervention: Other: debridement/dressing of wound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2017)
36
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02961699
Other Study ID Numbers  ICMJE CVSWH-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InGeneron, Inc.
Study Sponsor  ICMJE InGeneron, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bradley K Coots, M.D. Sanford Plastic and Reconstructive Surgery- Sioux Falls, SD
PRS Account InGeneron, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP