Wound, NonpenetratingNCT02961699
Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy
A study testing Transpose ® RT System and debridement/dressing of wound in people with Wound, Nonpenetrating, run by InGeneron, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Nonpenetrating
- What is being tested?
- Transpose ® RT System and debridement/dressing of wound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanford USD Medical Center
Sioux Falls, South Dakota, 57105
About this study
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
- Being tested
- Transpose ® RT System, debridement/dressing of wound
- Medical subject headings
- Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpose ® RT SystemDevice
adipose-derived stem cell therapy
debridement/dressing of woundOther
standard of care debridement and wound dressing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: debridement/dressing of wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: as indicated through adverse event rate between control versus experimental group
adverse event rate
Measured: 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
Measured: enrollment through 12 months of follow-up
Secondary outcomes (5)
Change in wound area over time (wound healing velocity)
size of wound will become smaller as measured during follow-up visits
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: enrollment through 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start1 Jun 2017
- Primary completionOct 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound, NonpenetratingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this study utilizes a medical device
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InGeneron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley K Coots, M.D., Principal investigator, Sanford Plastic and Reconstructive Surgery- Sioux Falls, SD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961699
- Sponsor's protocol ID
- CVSWH-001
- Status last verified
- Jul 2020
- First submitted
- 9 Nov 2016
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy
- ClinicalTrials.gov ID
- NCT02961699
- Acronym / sponsor ID
- CVSWH-001
- Conditions
- Wound, Nonpenetrating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- InGeneron, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- this study utilizes a medical device
| Arm | Type | Receives |
|---|---|---|
| Transpose ® RT System | Experimental | Device: Transpose ® RT SystemAdipose-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. |
| debridement/dressing of wound | Active comparator | Other: debridement/dressing of woundWound 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transpose ® RT Systemadipose-derived stem cell therapy | Device | Transpose ® RT System |
| debridement/dressing of woundstandard of care debridement and wound dressing | Other | debridement/dressing of wound |
Primary outcome
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
5 secondary outcomes
Change in wound area over time (wound healing velocity)
Time frame: enrollment through 12 months of follow-up
Percent decrease in wound size (length X width X depth)
Time frame: enrollment through 12 months of follow-up
Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life
Time frame: enrollment through 12 months of follow-up
Assessment of overall health status (questionnaire 36-Item Short Form/SF-36)
Time frame: enrollment through 12 months of follow-up
assessment of disease specific quality of life (questionnaire: CIVIQ-20)
Time frame: enrollment through 12 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley K Coots, M.D. principal investigator
Sanford Plastic and Reconstructive Surgery- Sioux Falls, SD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpose ® RT System and debridement/dressing of wound in people with Wound, Nonpenetrating, run by InGeneron, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: as indicated through adverse event rate between control versus experimental group (time frame: enrollment through 12 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.