Thermal BurnNCT03435172
Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds
A study testing Device-ADRCs intravenously infusion in people with Thermal Burn, run by Cytori Therapeutics at 5 sites in United States.
Trial summary
The primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thermal Burn
- What is being tested?
- Device-ADRCs intravenously infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2018to 31 Jul 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age ≥ 18 to ≤ 65
- BMI > 20 kg/m2
- Burn TBSA 20% - 50%
- At least one deep partial thickness and/or full thickness thermal burn ≥ 250 cm2 on the arms, legs, back, abdomen or chest that is anticipated to be covered with autologous meshed STSG meshed and that has not been treated previously with a biologic dressing such as Alloderm® or Integra®
- Ability to safely undergo tissue harvest that is anticipated to yield >150mL of adipose tissue at a site that is free from infection
- Donor site availability for skin graft harvest
- Able to provide written informed consent signed by either the patient or their legally authorized representative
- Women and men of child-bearing potential agreeing to use contraception during the study. Acceptable methods include surgical sterility, IUDs, hormonal contraception or double barrier methods
Who cannot join
- Subjects with burns > 3rd degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
- Subjects with electrical or chemical burns
- Subjects with significant inhalation injuries necessitating intubation and mechanical ventilation or requiring > 50% FI02 on a continuous basis to maintain oxygenation (02 sat > 90%)
- In the opinion of treating physician, patient not expected to survive beyond 30 days
- Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids
- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline
Show all 13Show fewer
- Known history of HIV infection, or active Hepatitis B or active Hepatitis C infection
- Cancer requiring chemotherapy or radiation within previous 6 months or resection within the last 5 years (other than basal cell carcinoma)
- Known chronic renal failure (serum creatinine > 2 mg/dL) or chronic liver disease
- Pre-existing medical conditions that would interfere with wound healing (i.e.diabetic patients with Hemoglobin A1c test result ≥8%, malignancy, autoimmune disease)
- Subjects with psychiatric conditions that are anticipated to result in protocol noncompliance
- Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient compliance with the protocol
- Participation in another clinical trial within 60 days of the screening visit
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio State University
Columbus, Ohio, 43210
University of Florida
Gainesville, Florida, 32610
Univeristy of Southern California
Los Angeles, California, 90033
Maricopa IHS
Phoenix, Arizona, 85008
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF)
The primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds.
Read the detailed description
The RELIEF Trial is a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wounds of > 250 cm2 that is to be autografted with a split thickness meshed skin graft (STSG). Subjects randomized to ADRCs will undergo small volume fat harvest (100 to 150 mL) performed at initiation of general anesthesia for scheduled burn surgery followed by intravenous delivery of ADRCs within 4 hours following surgery. The lipoaspirate will be processed in the Celution® System to isolate and concentrate ADRCs.
Following informed consent and initial screening assessments, eligible subjects will undergo pre-operative testing. On the procedure day, subjects will be randomized to ADRCs (with usual care) or usual care alone. Low volume lipoharvest will only be performed on subjects randomized to ADRCs in order to obtain 100-150 mL lipoaspirate, which will then be transferred to the Celution® System for processing to isolate and concentrate ADRCs for same-day administration. All treatment will be delivered in a total volume of 10 mL which will be delivered by slow intravenous administration into a peripheral vein.
Following surgery, subjects will be evaluated at first dressing change, day 10 (±2) (only if wound dressing change planned) and weeks 2 (±3 days), 3 (±3 days), 4 (±3 days), 8 (±7 days), 12 (±14 days), 26 (±14 days), and 52(±21 days).
The 1st 5 subjects enrolled in active treatment will be observed for adverse events over a 7 day period. If no SAEs occur during that period, for that individual subject, the next subject enrolled in active treatment may be entered with the same 7 day observation period. The safety results of the first 5 subjects will be reviewed by the DMC and their evaluation will be used in conjunction with the clinical data collected to date, and if appropriate, to potentially remove the staggering approach to the study. Enrollment after the first 5 subjects may continue only after the DMC has completed its safety review and recommends continuation.
- Conditions
- Thermal Burn
- Being tested
- Device-ADRCs intravenously infusion
- Keywords
- Thermal Burn, Adipose Derived Regenerative Cells, Skin Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device-ADRCs intravenously infusionDevice
Medical Device: ADRCs Generated by Celution 800 IV Device and then Infused into Peripheral Vein.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Device-ADRCs intravenously infusion 20 million ADRCs generated by Celution device will be intraveously infused through peripheral vein. Standard care of split thickness meshed skin graft (STSG) will be used. Receives: Device: Device-ADRCs intravenously infusion |
| Usual Care | No intervention | Standard care of split thickness meshed skin graft (STSG) will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of obtain lipo suction with > 100mL adipose tissue, Feasibility if obtain 20 million ADRC
Feasibility will be determined as 1) the ability to obtain > 100 mL adipose tissue during the liposuction surgical procedure (up to one hour for the tissue harvesting procedure), 2) obtain ≥ 20 x 106 ADRCs confirmed by cell counting (up to 4 hours after the liposuction procedure), and 3) deliver the prepared cell dose to the subject within four hours after Celution device completed the process.
Measured: Procedure day only
Incidence of Treatment-Emergent Adverse Events [Safety]
Safety will be evaluated based on the incidence, type and seriousness of adverse events related to the IV administration of test substance as well as the low volume lipoharvest procedure. Adverse events will be assessed according to the NIH Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for scale grading adverse events.
Measured: Throughout the whole 52 weeks trial evaluation period
Secondary outcomes (3)
Percent epithelialization of the graft
Percent epithelialization of the graft post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
Measured: At first dressing change, day 10 and weeks 2, 3 and 4.
Percent take of the graft
Percent take of the graft post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
Measured: At first dressing change, day 10 and weeks 2, 3 and 4.
Percent of wound with complete closure
Percent of wound closure post grafting (assessed by surgeon visual evaluation and blinded independent review of standardized photographs)
Measured: At weeks 2, 3, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Apr 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Why it stopped: Low enrollment rate, voluntary study suspension of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnStudies 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
- Subjects will have at least one deep partial or full thickness burn wound of ≥ 250 cm2 that is to be autografted with a split thickness meshed skin graft (STSG) . The Subjects will be randomized to treatment or usual care group at 2:1 ratio. Harvested tissue will be processed in the Celution® System to isolate and concentrate ADRCs. Then the subject will be followed by peripheral intravenous delivery of ADRCs within 4 hours of completion of Celution® processing. Up to 15 subjects will be enrolled. Each subject will contribute up to three qualified wound areas for the analysis. Randomization will be stratified to ensure that the numbers of wounds treated with STSG are balanced across the treatment groups.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc H Hedrick, MD, Principal investigator, Cytori therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435172
- Sponsor's protocol ID
- RELIEF
- Status last verified
- Sep 2019
- First submitted
- 1 Feb 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF)
- ClinicalTrials.gov ID
- NCT03435172
- Acronym / sponsor ID
- RELIEF
- Conditions
- Thermal Burn
- Keywords
- Thermal Burn, Adipose Derived Regenerative Cells, Skin Graft
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Low enrollment rate, voluntary study suspension of the study
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 15 Feb 2018 (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 primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds.
Detailed description
The RELIEF Trial is a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wounds of > 250 cm2 that is to be autografted with a split thickness meshed skin graft (STSG). Subjects randomized to ADRCs will undergo small volume fat harvest (100 to 150 mL) performed at initiation of general anesthesia for scheduled burn surgery followed by intravenous delivery of ADRCs within 4 hours following surgery. The lipoaspirate will be processed in the Celution® System to isolate and concentrate ADRCs.
Following informed consent and initial screening assessments, eligible subjects will undergo pre-operative testing. On the procedure day, subjects will be randomized to ADRCs (with usual care) or usual care alone. Low volume lipoharvest will only be performed on subjects randomized to ADRCs in order to obtain 100-150 mL lipoaspirate, which will then be transferred to the Celution® System for processing to isolate and concentrate ADRCs for same-day administration. All treatment will be delivered in a total volume of 10 mL which will be delivered by slow intravenous administration into a peripheral vein.
Following surgery, subjects will be evaluated at first dressing change, day 10 (±2) (only if wound dressing change planned) and weeks 2 (±3 days), 3 (±3 days), 4 (±3 days), 8 (±7 days), 12 (±14 days), 26 (±14 days), and 52(±21 days).
The 1st 5 subjects enrolled in active treatment will be observed for adverse events over a 7 day period. If no SAEs occur during that period, for that individual subject, the next subject enrolled in active treatment may be entered with the same 7 day observation period. The safety results of the first 5 subjects will be reviewed by the DMC and their evaluation will be used in conjunction with the clinical data collected to date, and if appropriate, to potentially remove the staggering approach to the study. Enrollment after the first 5 subjects may continue only after the DMC has completed its safety review and recommends continuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will have at least one deep partial or full thickness burn wound of ≥ 250 cm2 that is to be autografted with a split thickness meshed skin graft (STSG) . The Subjects will be randomized to treatment or usual care group at 2:1 ratio. Harvested tissue will be processed in the Celution® System to isolate and concentrate ADRCs. Then the subject will be followed by peripheral intravenous delivery of ADRCs within 4 hours of completion of Celution® processing. Up to 15 subjects will be enrolled. Each subject will contribute up to three qualified wound areas for the analysis. Randomization will be stratified to ensure that the numbers of wounds treated with STSG are balanced across the treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Device-ADRCs intravenously infusionDevice-ADRCs intravenously infusion 20 million ADRCs generated by Celution device will be intraveously infused through peripheral vein. Standard care of split thickness meshed skin graft (STSG) will be used. |
| Usual Care | No intervention | –Standard care of split thickness meshed skin graft (STSG) will be used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females age ≥ 18 to ≤ 65
- BMI > 20 kg/m2
- Burn TBSA 20% - 50%
- At least one deep partial thickness and/or full thickness thermal burn ≥ 250 cm2 on the arms, legs, back, abdomen or chest that is anticipated to be covered with autologous meshed STSG meshed and that has not been treated previously with a biologic dressing such as Alloderm® or Integra®
- Ability to safely undergo tissue harvest that is anticipated to yield >150mL of adipose tissue at a site that is free from infection
Key exclusion criteria (13 listed)
- Subjects with burns > 3rd degree (i.e. involvement of deeper tissues, such as muscle, tendons, or bone)
- Subjects with electrical or chemical burns
- Subjects with significant inhalation injuries necessitating intubation and mechanical ventilation or requiring > 50% FI02 on a continuous basis to maintain oxygenation (02 sat > 90%)
- In the opinion of treating physician, patient not expected to survive beyond 30 days
- Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids
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 |
|---|---|---|
| Device-ADRCs intravenously infusionMedical Device: ADRCs Generated by Celution 800 IV Device and then Infused into Peripheral Vein. | Device | Treatment Group |
Primary outcome
Feasibility of obtain lipo suction with > 100mL adipose tissue, Feasibility if obtain 20 million ADRC
Time frame: Procedure day only
Feasibility will be determined as 1) the ability to obtain > 100 mL adipose tissue during the liposuction surgical procedure (up to one hour for the tissue harvesting procedure), 2) obtain ≥ 20 x 106 ADRCs confirmed by cell counting (up to 4 hours after the liposuction procedure), and 3) deliver the prepared cell dose to the subject within four hours after Celution device completed the process.
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: Throughout the whole 52 weeks trial evaluation period
Safety will be evaluated based on the incidence, type and seriousness of adverse events related to the IV administration of test substance as well as the low volume lipoharvest procedure. Adverse events will be assessed according to the NIH Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for scale grading adverse events.
3 secondary outcomes
Percent epithelialization of the graft
Time frame: At first dressing change, day 10 and weeks 2, 3 and 4.
Percent take of the graft
Time frame: At first dressing change, day 10 and weeks 2, 3 and 4.
Percent of wound with complete closure
Time frame: At weeks 2, 3, 4, 8 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Marc H Hedrick, MD principal investigator
Cytori therapeutics Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device-ADRCs intravenously infusion in people with Thermal Burn, run by Cytori Therapeutics at 5 sites 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 8 inclusion and 13 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: paused, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Feasibility of obtain lipo suction with > 100mL adipose tissue, Feasibility if obtain 20 million ADRC (time frame: Procedure day only). 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 25 Sep 2019.