Chronic WoundsPhase 1NCT03882983
Stromal Vascular Fraction From Lipoaspirate to Treatment of Chronic Non-healing Wound
A Phase 1 study testing Antria Cell Preparation Process in people with Chronic Wounds, run by Antria at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Antria Cell Preparation Process
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to Dec 2022
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or Male, Age 18 years or older
- Subjects that are diagnosed with one or more chronic wounds.
- Able to understand and provide written and verbal informed consent
Who cannot join
- Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening.
- 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)
- 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)
- Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
Show all 10Show fewer
- 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.
- Subjects with life-expectancies less than 12 months
- Subjects with known collagenase allergies
- Pregnant females On radiotherapy or chemotherapy agents
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Indiana Regional Medical Center
Indiana, Pennsylvania, 15701
Leonard E Maliver, MD, 724-349-0520
About this study
Official title: A Phase I Safety Study Using Stromal Vascular Fraction From Lipoaspirate in the Treatment of Chronic Non-healing Wounds
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
Read the 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.
- Conditions
- Chronic Wounds
- Being tested
- Antria Cell Preparation Process
- Keywords
- Autologous Adult Stem Cell, Lipoaspirate, Non-healing Wounds, Stomal Vasular Fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antria Cell Preparation ProcessDrug
Also called SVF
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:
| Study group | Role | What they receive |
|---|---|---|
| Antria Cell Preparation Process | Experimental | Safety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments Receives: Drug: Antria Cell Preparation Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bates-Jensen Wound Assessment
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.
Measured: 1 year
Secondary outcomes (1)
Digital Picture of wound
Digital pictures of subject's wounds pre-treatment and post-treatment will be performed to show changed from baseline assessments.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Sep 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antria
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonard E Maliver, MD, Principal investigator, Antria Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882983
- Sponsor's protocol ID
- CW0001
- Status last verified
- Mar 2019
- First submitted
- 24 May 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety Study Using Stromal Vascular Fraction From Lipoaspirate in the Treatment of Chronic Non-healing Wounds
- ClinicalTrials.gov ID
- NCT03882983
- Acronym / sponsor ID
- CW0001
- Conditions
- Chronic Wounds
- Keywords
- Autologous Adult Stem Cell, Lipoaspirate, Non-healing Wounds, Stomal Vasular Fraction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AntriaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Mar 2019 (actual)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antria Cell Preparation Process | Experimental | Drug: Antria Cell Preparation ProcessSafety will be evaluated by collection of vital signs, EKG, patient surveys, and assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female or Male, Age 18 years or older
- Subjects that are diagnosed with one or more chronic wounds.
- Able to understand and provide written and verbal informed consent
Key exclusion criteria (10 listed)
- Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening.
- Diagnosis of any of the following medical conditions:
- 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)
- Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
- 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.
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 |
|---|---|---|
| Antria Cell Preparation ProcessAlso: SVFBiological/Vaccine: Stromal Vascular Fraction The SVF obtained from adipose tissue will be added to the graft Other Names: * Stromal Vascular Fraction * Adiployx Biological/Vaccine: | Drug | Antria Cell Preparation Process |
Primary outcome
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.
1 secondary outcome
Digital Picture of wound
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- 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.
Leonard E Maliver, MD principal investigator
Antria Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Antria Cell Preparation Process in people with Chronic Wounds, run by Antria 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 3 inclusion and 10 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 20 Mar 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Leonard E Maliver, MD (7243490520 ext. 7243490520, lmaliver@antria.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bates-Jensen Wound Assessment (time frame: 1 year). 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 20 Mar 2019.