Wound of SkinPhase 1NCT05797688
Adipose-derived Stem Cells to Treat Chronic Wounds.
A Phase 1 study testing The Celution System in people with Wound of Skin, run by Winthrop University Hospital at 1 site in United States.
Trial summary
The goal of this study is to determine whether autologous, adipose-derived regenerative cells improve the healing of chronic wounds. Ten patients will undergo fat harvest and peri-wound injection of the isolated cells in addition to the standard of care for the treatment of their chronic wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin
- What is being tested?
- The Celution System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Sep 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must agree to adhere to all protocol procedures and return for weekly scheduled wound assessment visits, including requirements for taking and abstaining from medications.
- Subject is willing and able to read, understand and sign a written Informed Consent to participate in the study or have an appropriate representative available to do so.
- Subject must have a full thickness Stage III or Stage IV pressure ulcer, deep venous ulcer, deep diabetic ulcer, ischemic ulcer, abdominal wound, nonhealing surgical site or sickle cell ulcer. For subjects with more than one wound that meet these criteria, the largest qualifying wound will be treated.
- Subject has adequate (>200 mL) abdominal or other subcutaneous adipose tissue accessible by syringe-based fat harvest and is able to undergo a fat harvest procedure in the opinion of the investigator or per facility guidelines and has activated platelet thromboplastin time (aPTT) within the normal reference range at the time of the fat harvest procedure and no contraindication to fat harvest.
- Subject's wound has been refractory to standard of care (no objective/measureable signs of healing) for at least 30 days.
Who cannot join
- Subject has local infection with erythema > 2 cm, or involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis), or associated with local wound complications such as prosthetic materials or protruding surgical hardware.
- Subject has ≥ 2 of the following signs of systemic inflammatory response syndrome (SIRS) or septic shock within 7 days of screening:
- Temperature > 38°C or < 36°C
- Heart rate > 90 beats/min
- Respiratory rate > 20 breaths/min or PaCO2 < 32 mm Hg
- White blood cell count > 12,000 or < 4,000 cells/μL or ≥ 10% immature (band) forms.
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- Subject has received biologic or cell therapy within 12 weeks of initiation of the study.
- Subject not eligible for syringe-based liposuction of at least 200 mL of subcutaneous adipose tissue, including therapeutic anticoagulation with INR >1.7 or PTT >60, or receiving GIIb/IIIa inhibitors within 2 weeks prior to the study.
- Subject has squamous cell carcinoma, basal cell carcinoma, melanoma or skin carcinoma of the affected limb or area and underwent treatment within the last year.
- Subject is pregnant as determined by a positive pregnancy test prior to procedure, or breast-feeding.
- Clinically significant abnormal findings on laboratory screening panels, including hemoglobin ≤10 g/dL.
- Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotranferase (ALT), or bilirubin level > 1.5 times the upper limit of normal range (x ULN) prior to randomization.
- Chronic renal insufficiency as defined as a serum creatinine > 2.0 mg/dL or requires dialysis.
- History of organ transplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: Use of Autologous Adipose-derived Stem Cell to Treat Chronic Wounds
The goal of this study is to determine whether autologous, adipose-derived regenerative cells improve the healing of chronic wounds. Ten patients will undergo fat harvest and peri-wound injection of the isolated cells in addition to the standard of care for the treatment of their chronic wound. Wound healing will be followed over 24 weeks.
Read the detailed description
This study will be an open-label, preliminary, proof-of-concept trial. Ten patients will undergo debridement of their wound per the standard of care currently offered by Winthrop University Hospital along with concurrent fat harvest according to the standard protocols of the Winthrop University Hospital Plastic surgeons. The harvested fat will be immediately processed using an automated system to isolate regenerative cells, including stem cells. This will be followed by same-day subcutaneous injection of the isolated cells into the debrided wound site. The patients will then undergo weekly wound debridements according to the current standard of care treatment protocols. They will be followed weekly for 24 weeks in the outpatient wound clinic and observed for pain, erythema of the injection site, wound infection, edema, fever, bleeding and wound healing as measured by wound size and area. Fat harvest and subcutaneous injection will be repeated 3 months after the initial procedure if the wound has not decreased in size by at least 40%. Patients can undergo a maximum of 2 cycles of fat harvest and cell injection.
- Conditions
- Wound of Skin
- Being tested
- The Celution System
- Keywords
- Chronic Wound, Chronic Ulcer, stem cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Celution SystemDevice
Also called Celution, Adipose-derived cell processor
The Celution System will isolate regenerative cells, including stem cells, from fat harvested from the treatment patients.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients will undergo a fat harvest procedure and the tissue will then be processed by The Celution System to isolate a 5 mL aliquot including stem cells. This will then be injected into the base and within in perimeter of the target wound. Receives: Device: The Celution System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by weekly evalutation of the occurrence of wound infection, redness, swelling, pain, fever, chills, bleeding, and wound healing.
Measured: 1 year
Secondary outcomes (2)
Complete wound healing
Wounds will be evaluated for 100% epithelialization with no drainage.
Measured: 1 year
Time to healing
The time when complete healing occurs will be recorded, up to 1 year.
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 posted4 Apr 2023
- Study startDec 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cytori Therapeutics
- Responsible party
- Sponsor
- Investigators
- Harold Brem, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797688
- Sponsor's protocol ID
- 15586
- Status last verified
- Dec 2016
- First submitted
- 23 Dec 2016
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Adipose-derived Stem Cell to Treat Chronic Wounds
- ClinicalTrials.gov ID
- NCT05797688
- Acronym / sponsor ID
- 15586
- Conditions
- Wound of Skin
- Keywords
- Chronic Wound, Chronic Ulcer, stem cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Collaborators
- Cytori Therapeutics
- Study start
- Dec 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 4 Apr 2023 (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.
The goal of this study is to determine whether autologous, adipose-derived regenerative cells improve the healing of chronic wounds. Ten patients will undergo fat harvest and peri-wound injection of the isolated cells in addition to the standard of care for the treatment of their chronic wound. Wound healing will be followed over 24 weeks.
Detailed description
This study will be an open-label, preliminary, proof-of-concept trial. Ten patients will undergo debridement of their wound per the standard of care currently offered by Winthrop University Hospital along with concurrent fat harvest according to the standard protocols of the Winthrop University Hospital Plastic surgeons. The harvested fat will be immediately processed using an automated system to isolate regenerative cells, including stem cells. This will be followed by same-day subcutaneous injection of the isolated cells into the debrided wound site. The patients will then undergo weekly wound debridements according to the current standard of care treatment protocols. They will be followed weekly for 24 weeks in the outpatient wound clinic and observed for pain, erythema of the injection site, wound infection, edema, fever, bleeding and wound healing as measured by wound size and area. Fat harvest and subcutaneous injection will be repeated 3 months after the initial procedure if the wound has not decreased in size by at least 40%. Patients can undergo a maximum of 2 cycles of fat harvest and cell injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: The Celution SystemPatients will undergo a fat harvest procedure and the tissue will then be processed by The Celution System to isolate a 5 mL aliquot including stem cells. This will then be injected into the base and within in perimeter of the target wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must agree to adhere to all protocol procedures and return for weekly scheduled wound assessment visits, including requirements for taking and abstaining from medications.
- Subject is willing and able to read, understand and sign a written Informed Consent to participate in the study or have an appropriate representative available to do so.
- Subject must have a full thickness Stage III or Stage IV pressure ulcer, deep venous ulcer, deep diabetic ulcer, ischemic ulcer, abdominal wound, nonhealing surgical site or sickle cell ulcer. For subjects with more than one wound that meet these criteria, the largest qualifying wound will be treated.
- Subject has adequate (>200 mL) abdominal or other subcutaneous adipose tissue accessible by syringe-based fat harvest and is able to undergo a fat harvest procedure in the opinion of the investigator or per facility guidelines and has activated platelet thromboplastin time (aPTT) within the normal reference range at the time of the fat harvest procedure and no contraindication to fat harvest.
- Subject's wound has been refractory to standard of care (no objective/measureable signs of healing) for at least 30 days.
Key exclusion criteria (14 listed)
- Subject has local infection with erythema > 2 cm, or involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis), or associated with local wound complications such as prosthetic materials or protruding surgical hardware.
- Subject has ≥ 2 of the following signs of systemic inflammatory response syndrome (SIRS) or septic shock within 7 days of screening:
- Subject has received biologic or cell therapy within 12 weeks of initiation of the study.
- Subject not eligible for syringe-based liposuction of at least 200 mL of subcutaneous adipose tissue, including therapeutic anticoagulation with INR >1.7 or PTT >60, or receiving GIIb/IIIa inhibitors within 2 weeks prior to the study.
- Subject has squamous cell carcinoma, basal cell carcinoma, melanoma or skin carcinoma of the affected limb or area and underwent treatment within the last year.
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 |
|---|---|---|
| The Celution SystemAlso: Celution, Adipose-derived cell processorThe Celution System will isolate regenerative cells, including stem cells, from fat harvested from the treatment patients. | Device | Treatment |
Primary outcome
Safety as assessed by weekly evalutation of the occurrence of wound infection, redness, swelling, pain, fever, chills, bleeding, and wound healing.
Time frame: 1 year
2 secondary outcomes
Complete wound healing
Time frame: 1 year
Time to healing
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- 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.
Harold Brem, MD principal investigator
Winthrop University Hospital
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 The Celution System in people with Wound of Skin, run by Winthrop University Hospital 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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 4 Apr 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 assessed by weekly evalutation of the occurrence of wound infection, redness, swelling, pain, fever, chills, bleeding, and wound healing. (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 4 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.