Acute Deep Partial Thickness Thermal BurnsPhase 1NCT02169362

Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries

A Phase 1 study testing Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) in people with Acute Deep Partial Thickness Thermal Burns, run by Arteriocyte, Inc. at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound. Read more about this study

Who is it for?: Ages 18 to 86 years
Conditions the study is for: Acute Deep Partial Thickness Thermal Burns
What is being tested?: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 8 sitesUnited States
Study dates: Jul 2014to May 2018
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 to 86 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent will be obtained prior to study participation
Male or female age ≥ 18 years of age or ≤ 86 years of age
Total burn wound measuring ≤ 25% TBSA
Burn wound area to be treated must be a deep partial thickness wound
Burn wound area to be treated must be ≤72 cm2 and surrounded by a perimeter of healthy skin
Able and willing to comply with the procedures required by the protocol. Subjects may be managed as either inpatient or outpatient.

Show all 14Show fewer

If a female of childbearing potential, the subject must have a negative serum pregnancy test at screening
All subjects, male and female, must use acceptable method(s) of birth control for the duration of the study
Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry)
A partner who is physically unable to impregnate the subject (e.g., vasectomized)
Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to subject's cell concentrate administration
Intrauterine device (IUD), or
Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)

Who cannot join

Conductive electrical, friction or chemical burns
Burns to the digits, head, genitalia, palms of hands, soles of feet, and face that are the only possible sites for treatment (subjects with burns elsewhere in addition to these sites may be enrolled in the study)
Burns that pose a risk to digits or limbs
Subjects who have gone into hemorrhagic shock following burn injury
Subject was medically treated for insulin-dependent or non-insulin-dependent diabetes mellitus prior to burn injury per subject medical history
Venous or arterial vascular disorder directly affecting a designated test area

Show all 27Show fewer

Known immune deficiency disorder, either congenital or acquired
Chronically malnourished as determined clinically by the investigator. (Investigators are responsible for determining if subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: medical history and physical appearance, the subject's body mass index, and any significant laboratory findings)
Severe respiratory problems or concurrent head trauma at hospital admission, including inhalation injury requiring ventilator support
Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
Use of COX-1 and/or COX-2 inhibitors within 48 hours prior to treatment. Subjects must refrain from use of NSAIDs for five days after Visit 2.
Any other acute or chronic concurrent medical condition(s) that, in the investigator's opinion, are a contraindication to study participation or limit the subject's life expectancy to < 6 months
Known or suspected hypersensitivity to Recothrom®
Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial)
Females who are pregnant or nursing or intend to become pregnant during the duration of the study
Burn wounds that occur over joints
Known allergies to silver, adhesive products or silicone.
Subjects with the following abnormal laboratory test levels:
Stage 4 or greater chronic kidney disease (eGFR < 30 mL/min
Hemoglobin < 10 g/dl
Thrombocytopenia < 100,000 platelets/µl.
Serum albumin level < 2.5 g/dl or > 30 g/dl at time of screening
Liver function*:
AST- Males and Females, >2.5 ULN
ALT- Males and Females, >2.5 ULN
Alkaline Phosphatase- Males and Females: >2.0 ULN
Total bilirubin- Males and Females >2.0 ULN

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Jaycee Burn Center at University of North Carolina
Chapel Hill, North Carolina, 27599
University Medical Center Southern Nevada, Lions Regional Burn Center
Las Vegas, Nevada, 89102
Firefighters' Regional Burn Center
Memphis, Tennessee, 38104
Arizona Burn Center
Phoenix, Arizona, 85008
University of California, Davis Medica Center
Sacramento, California, 95817
Tampa General Hospital/University of South Florida
Tampa, Florida, 33606
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Phase I, Double-Blind, Randomized, Controlled Study to Demonstrate the Safety of Applying Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) to Acute Deep Partial Thickness Thermal Injuries

The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound.

Read the detailed description

The objective of this trial is to demonstrate the safety of applying autologous PRP gel (Magellan® Bio-Bandage™) to acute deep partial thickness thermal burns in the first days after burn injury.

The Magellan® Bio-Bandage™ Burn Wound Care Kit is intended for the preparation and application of an autologous biological covering to deep partial thickness burn wounds to delay or minimize skin grafting requirements.

Conditions: Acute Deep Partial Thickness Thermal Burns
Being tested: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)
Keywords: Burns, Thermal burns, Second degree burns, Partial thickness burns, Deep partial thickness burns, Acute burns, Burn wounds
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)Device
Also called The Magellan® System
Application of up to 18 mL of autologous PRP gel (Magellan® Bio-Bandage™) to the surface of an acute deep partial thickness burn wound no greater than 72 cm squared within 72 hours of the initial injury. Intervention is in addition to standard of care treatment. The PRP Bio-Bandage™ is prepared using the Magellan® System and is FDA cleared via BK030040 and BK040068.

Study groups in NCT02169362
Study group	Role	What they receive
Platelet Rich Plasma - Bio-Bandage™	Experimental	Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) Receives: Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)
Saline Spray, Standard of Care	Sham comparator	Not described Receives: Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety as measured by Adverse Events
The primary objective of this trial is to demonstrate the safety of applying autologous PRP gel to acute deep partial thickness thermal burns in the first days after burn injury. The primary endpoint of this study will be safety. Incidence of Adverse Events and/or Serious Adverse Events will be documented, along with time to wound closure.
Measured: Days 1 -365

Secondary outcomes (5)

Delay or minimization of skin grafting requirements following burn injury
This outcome will be evaluated by time to graft (days), need for graft (yes or no), and incidence of graft occurrence ( percentage of subjects in control group versus treatment group requiring a skin graft).
Measured: Change will be assessed up to 35 Days
Improved wound healing trajectory as compared to standard of care
Wound healing will be assessed by calculating wound size measurements and percentage of change over time utilizing digital photography and planimetry software.
Measured: Change will be assessed up to 365 Days
Increased rate of wound closure as compared to standard of care
The percentage of treated subjects versus standard of care only subjects with complete wound closure at 28 and 42 days post-burn injury. Wound closure will be defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive visits.
Measured: Change will be assessed up to 365 Days
Reduced scarring, pain and pruritus
This outcome will compare treated subjects to standard of care only subjects by analyzing photo images and scar scale analysis (principal investigator and blinded rater assessments), and based on subject reported pain and pruritus.
Measured: Change will be assessed up to 365 Days
Improved Skin-Healing Quality
Histological analysis of 2mm skin biopsies taken at Baseline (Day 1) and 90 days post-treatment will be analyzed and compared. Biopsies will be taken only from subject for whom a skin graft was not required, and from both treated subjects and standard of care only subjects.
Measured: Change will be assessed up to 365 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014May 2018

First posted23 Jun 2014 (estimated)
Study startJul 2014
Primary completionJan 2018 (estimated)
Study completionMay 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Acute Deep Partial Thickness Thermal BurnsStudies 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: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02169362
Sponsor's protocol ID: ART 13-005
Other IDs: IDE 15921
Status last verified: Jan 2017
First submitted: 23 May 2014
Last updated: 13 Apr 2017
Results posted: No
Data monitoring committee: Yes

Publications

Badiavas AR, Badiavas EV. Potential benefits of allogeneic bone marrow mesenchymal stem cells for wound healing. Expert Opin Biol Ther. 2011 Nov;11(11):1447-54. doi: 10.1517/14712598.2011.606212. Epub 2011 Aug 20.
PubMed 21854302
Barr JE. Principles of wound cleansing. Ostomy Wound Manage. 1995 Aug;41(7A Suppl):15S-21S; discussion 22S.
PubMed 7669196
Almdahl SM, Veel T, Halvorsen P, Vold MB, Molstad P. Randomized prospective trial of saphenous vein harvest site infection after wound closure with and without topical application of autologous platelet-rich plasma. Eur J Cardiothorac Surg. 2011 Jan;39(1):44-8. doi: 10.1016/j.ejcts.2010.06.007. Epub 2010 Jul 15.
PubMed 20634084
Bielecki TM, Gazdzik TS, Arendt J, Szczepanski T, Krol W, Wielkoszynski T. Antibacterial effect of autologous platelet gel enriched with growth factors and other active substances: an in vitro study. J Bone Joint Surg Br. 2007 Mar;89(3):417-20. doi: 10.1302/0301-620X.89B3.18491.
PubMed 17356164
Boswell SG, Cole BJ, Sundman EA, Karas V, Fortier LA. Platelet-rich plasma: a milieu of bioactive factors. Arthroscopy. 2012 Mar;28(3):429-39. doi: 10.1016/j.arthro.2011.10.018. Epub 2012 Jan 28.
PubMed 22284405
Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.
PubMed 21042116
Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006 Apr;19(2):403-34. doi: 10.1128/CMR.19.2.403-434.2006.
PubMed 16614255
Dib N, Michler RE, Pagani FD, Wright S, Kereiakes DJ, Lengerich R, Binkley P, Buchele D, Anand I, Swingen C, Di Carli MF, Thomas JD, Jaber WA, Opie SR, Campbell A, McCarthy P, Yeager M, Dilsizian V, Griffith BP, Korn R, Kreuger SK, Ghazoul M, MacLellan WR, Fonarow G, Eisen HJ, Dinsmore J, Diethrich E. Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy: four-year follow-up. Circulation. 2005 Sep 20;112(12):1748-55. doi: 10.1161/CIRCULATIONAHA.105.547810.
PubMed 16172284
Erbs S, Linke A, Adams V, Lenk K, Thiele H, Diederich KW, Emmrich F, Kluge R, Kendziorra K, Sabri O, Schuler G, Hambrecht R. Transplantation of blood-derived progenitor cells after recanalization of chronic coronary artery occlusion: first randomized and placebo-controlled study. Circ Res. 2005 Oct 14;97(8):756-62. doi: 10.1161/01.RES.0000185811.71306.8b. Epub 2005 Sep 8.
PubMed 16151021
Farrior E, Ladner K. Platelet gels and hemostasis in facial plastic surgery. Facial Plast Surg. 2011 Aug;27(4):308-14. doi: 10.1055/s-0031-1283050. Epub 2011 Jul 26.
PubMed 21792775
Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
PubMed 20596233
Fearmonti RM, Bond JE, Erdmann D, Levin LS, Pizzo SV, Levinson H. The modified Patient and Observer Scar Assessment Scale: a novel approach to defining pathologic and nonpathologic scarring. Plast Reconstr Surg. 2011 Jan;127(1):242-247. doi: 10.1097/PRS.0b013e3181f959e8.
PubMed 21200219
Forrester JS, Price MJ, Makkar RR. Stem cell repair of infarcted myocardium: an overview for clinicians. Circulation. 2003 Sep 2;108(9):1139-45. doi: 10.1161/01.CIR.0000085305.82019.65. No abstract available.
PubMed 12952828
Gunaydin S, McCusker K, Sari T, Onur M, Gurpinar A, Sevim H, Atasoy P, Yorgancioglu C, Zorlutuna Y. Clinical impact and biomaterial evaluation of autologous platelet gel in cardiac surgery. Perfusion. 2008 May;23(3):179-86. doi: 10.1177/0267659108097783.
PubMed 19029269
Jorgensen B, Karlsmark T, Vogensen H, Haase L, Lundquist R. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds. Int J Low Extrem Wounds. 2011 Dec;10(4):218-23. doi: 10.1177/1534734611426755. Epub 2011 Oct 18.
PubMed 22009148

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Double-Blind, Randomized, Controlled Study to Demonstrate the Safety of Applying Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) to Acute Deep Partial Thickness Thermal Injuries
ClinicalTrials.gov ID: NCT02169362
Acronym / sponsor ID: ART 13-005
Conditions: Acute Deep Partial Thickness Thermal Burns
Keywords: Burns, Thermal burns, Second degree burns, Partial thickness burns, Deep partial thickness burns, Acute burns, Burn wounds
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 36 participants (actual)
Lead sponsor: Arteriocyte, Inc.Industry (pharma, biotech, devices)
Collaborators: Department of Health and Human Services
Study start: Jul 2014
Primary completion: Jan 2018 (estimated)
Study completion: May 2018 (estimated)
First posted: 23 Jun 2014 (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.

The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound.

Detailed description

The objective of this trial is to demonstrate the safety of applying autologous PRP gel (Magellan® Bio-Bandage™) to acute deep partial thickness thermal burns in the first days after burn injury.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Platelet Rich Plasma - Bio-Bandage™	Experimental	Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)
Saline Spray, Standard of Care	Sham comparator	Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)

Who may qualify

Ages: 18 to 86 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Informed consent will be obtained prior to study participation
Male or female age ≥ 18 years of age or ≤ 86 years of age
Total burn wound measuring ≤ 25% TBSA
Burn wound area to be treated must be a deep partial thickness wound
Burn wound area to be treated must be ≤72 cm2 and surrounded by a perimeter of healthy skin

Key exclusion criteria (27 listed)

Conductive electrical, friction or chemical burns
Burns to the digits, head, genitalia, palms of hands, soles of feet, and face that are the only possible sites for treatment (subjects with burns elsewhere in addition to these sites may be enrolled in the study)
Burns that pose a risk to digits or limbs
Subjects who have gone into hemorrhagic shock following burn injury
Subject was medically treated for insulin-dependent or non-insulin-dependent diabetes mellitus prior to burn injury per subject medical history

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
Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)Also: The Magellan® SystemApplication of up to 18 mL of autologous PRP gel (Magellan® Bio-Bandage™) to the surface of an acute deep partial thickness burn wound no greater than 72 cm squared within 72 hours of the initial injury. Intervention is in addition to standard of care treatment. The PRP Bio-Bandage™ is prepared using the Magellan® System and is FDA cleared via BK030040 and BK040068.	Device	Platelet Rich Plasma - Bio-Bandage™, Saline Spray, Standard of Care

Primary outcome

Safety as measured by Adverse Events
Time frame: Days 1 -365
The primary objective of this trial is to demonstrate the safety of applying autologous PRP gel to acute deep partial thickness thermal burns in the first days after burn injury. The primary endpoint of this study will be safety. Incidence of Adverse Events and/or Serious Adverse Events will be documented, along with time to wound closure.

5 secondary outcomes

Delay or minimization of skin grafting requirements following burn injury
Time frame: Change will be assessed up to 35 Days
Improved wound healing trajectory as compared to standard of care
Time frame: Change will be assessed up to 365 Days
Increased rate of wound closure as compared to standard of care
Time frame: Change will be assessed up to 365 Days
Reduced scarring, pain and pruritus
Time frame: Change will be assessed up to 365 Days
Improved Skin-Healing Quality
Time frame: Change will be assessed up to 365 Days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Background: PubMed 21854302Badiavas AR, Badiavas EV. Potential benefits of allogeneic bone marrow mesenchymal stem cells for wound healing. Expert Opin Biol Ther. 2011 Nov;11(11):1447-54. doi: 10.1517/14712598.2011.606212. Epub 2011 Aug 20.
Background: PubMed 7669196Barr JE. Principles of wound cleansing. Ostomy Wound Manage. 1995 Aug;41(7A Suppl):15S-21S; discussion 22S.
Background: PubMed 20634084Almdahl SM, Veel T, Halvorsen P, Vold MB, Molstad P. Randomized prospective trial of saphenous vein harvest site infection after wound closure with and without topical application of autologous platelet-rich plasma. Eur J Cardiothorac Surg. 2011 Jan;39(1):44-8. doi: 10.1016/j.ejcts.2010.06.007. Epub 2010 Jul 15.
Background: PubMed 17356164Bielecki TM, Gazdzik TS, Arendt J, Szczepanski T, Krol W, Wielkoszynski T. Antibacterial effect of autologous platelet gel enriched with growth factors and other active substances: an in vitro study. J Bone Joint Surg Br. 2007 Mar;89(3):417-20. doi: 10.1302/0301-620X.89B3.18491.
Background: PubMed 22284405Boswell SG, Cole BJ, Sundman EA, Karas V, Fortier LA. Platelet-rich plasma: a milieu of bioactive factors. Arthroscopy. 2012 Mar;28(3):429-39. doi: 10.1016/j.arthro.2011.10.018. Epub 2012 Jan 28.
Background: PubMed 21042116Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.
Background: PubMed 16614255Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006 Apr;19(2):403-34. doi: 10.1128/CMR.19.2.403-434.2006.
Background: PubMed 16172284Dib N, Michler RE, Pagani FD, Wright S, Kereiakes DJ, Lengerich R, Binkley P, Buchele D, Anand I, Swingen C, Di Carli MF, Thomas JD, Jaber WA, Opie SR, Campbell A, McCarthy P, Yeager M, Dilsizian V, Griffith BP, Korn R, Kreuger SK, Ghazoul M, MacLellan WR, Fonarow G, Eisen HJ, Dinsmore J, Diethrich E. Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy: four-year follow-up. Circulation. 2005 Sep 20;112(12):1748-55. doi: 10.1161/CIRCULATIONAHA.105.547810.
Background: PubMed 16151021Erbs S, Linke A, Adams V, Lenk K, Thiele H, Diederich KW, Emmrich F, Kluge R, Kendziorra K, Sabri O, Schuler G, Hambrecht R. Transplantation of blood-derived progenitor cells after recanalization of chronic coronary artery occlusion: first randomized and placebo-controlled study. Circ Res. 2005 Oct 14;97(8):756-62. doi: 10.1161/01.RES.0000185811.71306.8b. Epub 2005 Sep 8.
Background: PubMed 21792775Farrior E, Ladner K. Platelet gels and hemostasis in facial plastic surgery. Facial Plast Surg. 2011 Aug;27(4):308-14. doi: 10.1055/s-0031-1283050. Epub 2011 Jul 26.
Background: PubMed 20596233Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
Background: PubMed 21200219Fearmonti RM, Bond JE, Erdmann D, Levin LS, Pizzo SV, Levinson H. The modified Patient and Observer Scar Assessment Scale: a novel approach to defining pathologic and nonpathologic scarring. Plast Reconstr Surg. 2011 Jan;127(1):242-247. doi: 10.1097/PRS.0b013e3181f959e8.

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.

Brian Barnes, PhD study director

Arteriocyte, Inc.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 27 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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. Some participants in this study may receive a placebo. 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?

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 measured by Adverse Events (time frame: Days 1 -365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02169362, which also lists 26 linked publications.

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 13 Apr 2017.