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Trial record 13 of 112 for:    stromal vascular fraction

Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound

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ClinicalTrials.gov Identifier: NCT03882983
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Antria

Tracking Information
First Submitted Date  ICMJE May 24, 2017
First Posted Date  ICMJE March 20, 2019
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Bates-Jensen Wound Assessment [ Time Frame: 1 year ]
This assessment focuses on analysis wounds with regards to the following information: size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding the wound, peripheral tissue edema and induration, granulation tissue, and epithelialization. Each item will be measured on a scale 1-5. A score of 1 will indicate least severe and a score of 5 will indicate the most severe.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Digital Picture of wound [ Time Frame: 1 year ]
Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound
Official Title  ICMJE A Phase I Safety Study Using Stromal Vascular Fraction From Lipoaspirate in the Treatment of Chronic Non-healing Wounds
Brief Summary This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds
Detailed Description This is a Phase I, open-label, single arm study to demonstrate the safety of Antria Cell Preparation Process during fat grafting augmented with autologous adipose derived stromal vascular fraction to demonstrate the safety and efficacy of administration of SVF enriched fat grafting in chronic wounds.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Wounds
Intervention  ICMJE Drug: Antria Cell Preparation Process

Biological/Vaccine: Stromal Vascular Fraction The SVF obtained from adipose tissue will be added to the graft

Other Names:

  • Stromal Vascular Fraction
  • Adiployx Biological/Vaccine:
Other Name: SVF
Study Arms  ICMJE Experimental: Antria Cell Preparation Process
Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments
Intervention: Drug: Antria Cell Preparation Process
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female or Male, Age 18 years or older
  2. Subjects that are diagnosed with one or more chronic wounds.
  3. Able to understand and provide written and verbal informed consent

Exclusion Criteria:

  1. Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening.
  2. Diagnosis of any of the following medical conditions:

    • Active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer)
    • Active infection (other than their wound)
  3. Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the Investigator to be unlikely to complete the study)
  4. Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
  5. Any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase the risk for subjects.
  6. Subjects with life-expectancies less than 12 months
  7. Subjects with known collagenase allergies
  8. Pregnant females On radiotherapy or chemotherapy agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Leonard E Maliver, MD 7243490520 ext 7243490520 lmaliver@antria.org
Contact: Sarah C Boyer, MS, MA 7243490520 ext 7243490520 sboyer@antria.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03882983
Other Study ID Numbers  ICMJE CW0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Antria
Study Sponsor  ICMJE Antria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonard E Maliver, MD Antria Inc.
PRS Account Antria
Verification Date March 2019

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