Compartment SyndromePhase 1Magellan MAR01NCT01837264
Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma
A Phase 1 study testing Magellan® in people with Compartment Syndrome, run by Arteriocyte, Inc. at 1 site in United States.
Trial summary
Compartment syndrome (CS) is a condition resulting from increased pressure within a compartment, which compromises circulation and can lead to critical limb ischemia. CS is one of the biggest medical challenges that our soldiers face after battlefield related injuries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Compartment Syndrome
- What is being tested?
- Magellan®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is able to provide signed, written informed consent prior to study entry
- Speaks English
- compartment fasciotomy of tibial compartment
- Sufficient skin for primary closure
- Is male or female, 18 - 65 years of age
- ABI less than 0.7, ankle pressure < 50 mmHg, or toe pressure < 30 mmHg.
Show all 11Show fewer
- TcPO2 < 40 mmHg.
- 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 patient's cell concentrate administration, Intrauterine device (IUD), or Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
- If female of childbearing potential, subject must have a negative urine pregnancy test at screening
- Confirmation of age-appropriate cancer screening consistent with the American Cancer Society guidelines.
Who cannot join
- Prior compartment syndrome fracture of same limb
- Previous fracture of the same limb
- Any contraindication to stem cell or platelet-rich plasma therapy.
- Pregnancy
- Have an active malignancy or have undergone treatment for a malignancy in the preceding 5 years, with the exception of successful treatment of non-melanoma skin cancer.
- Stage 4 or greater chronic kidney disease (eGFR < 30 ml/min, MDRD estimate).
Show all 11Show fewer
- Unwilling or unable to comply with follow-up visits.
- Is unable to refrain from nicotine, caffeine and alcohol for a period beginning 24 hours prior to the treatment visit
- Has received an investigational medication or other study trial participation within 30 days prior to the Treatment Visit
- Prisoner
- Non-English Speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
About this study
Official title: Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma Study Protocol
Compartment syndrome (CS) is a condition resulting from increased pressure within a compartment, which compromises circulation and can lead to critical limb ischemia. CS is one of the biggest medical challenges that our soldiers face after battlefield related injuries. Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute compartment syndrome is a medical emergency requiring surgery. Treatment of compartment syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to evaluate the feasibility and safety of the administration of marrow-derived autologous bone marrow concentrate and PRP gel generated by a point of care marrow separation system for the treatment of compartment syndrome. And to show this treatment possibly enhances wound healing, bone healing, perfusion, infection control, and the return of limb function in patients with CS.
Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and wound healing have predominantly focused on the mechanism of action of a single stem cell population to achieve neovascularization and improve tissue perfusion. It is well documented that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF, bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's development efforts focus on concentration of autologous bone marrow-derived stem cells and platelets for delivery to the site of injury in a concentration sufficient to effect local tissue revascularization and repair. These products provide for the rapid, bedside preparation of autologous PRP and bone marrow stem cell concentrate.
This clinical trial with the Magellan® System is for the preparation of autologous cell concentrate for the treatment of wound, tissue and bone healing, improved perfusion, infection control, and the return of limb function in patients at risk of amputation.
- Conditions
- Compartment Syndrome
- Being tested
- Magellan®
- Keywords
- Magellan MAR01, Autologous Platelet Rich Plasma, Compartment Syndrome, Battlefield Trauma, Fasciotomy
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magellan®Device
Also called autologous cell concentrate, autologous Bone Marrow Cell Concentrate Using the Magellan® System
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Cell Concentrate | Experimental | Not described Receives: Device: Magellan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure or death
- Measurement of rate of infection in the study population
- Complications due to wound and/or therapy
- Amputation of limb and/or death
Measured: 12 months
Secondary outcomes (1)
Perfusion and quality of life measurements
Wound healing (rate and qualitative healing assessment)
- Bone healing (Radiographic assessment)
- Tissue perfusion (ABI; TcPO2)
- Limb pain (pain score assessment)
- Functional performance vs. uninjured limb
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Compartment SyndromeStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arteriocyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Barnes, PhD, Study director, Arteriocyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837264
- Sponsor's protocol ID
- ART-11-003
- Acronym
- Magellan MAR01
- Status last verified
- Jan 2017
- First submitted
- 17 Apr 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ritenour AE, Dorlac WC, Fang R, Woods T, Jenkins DH, Flaherty SF, Wade CE, Holcomb JB. Complications after fasciotomy revision and delayed compartment release in combat patients. J Trauma. 2008 Feb;64(2 Suppl):S153-61; discussion S161-2. doi: 10.1097/TA.0b013e3181607750.
PubMed 18376159Ateschrang A, Ochs BG, Ludemann M, Weise K, Albrecht D. Fibula and tibia fusion with cancellous allograft vitalised with autologous bone marrow: first results for infected tibial non-union. Arch Orthop Trauma Surg. 2009 Jan;129(1):97-104. doi: 10.1007/s00402-008-0699-2. Epub 2008 Aug 2.
PubMed 18677497Sebecic B, Gabelica V, Patrlj L, Sosa T. Percutaneous autologous bone marrow grafting on the site of tibial delayed union. Croat Med J. 1999 Sep;40(3):429-32.
PubMed 10411974Umemura T, Nishioka K, Igarashi A, Kato Y, Ochi M, Chayama K, Yoshizumi M, Higashi Y. Autologous bone marrow mononuclear cell implantation induces angiogenesis and bone regeneration in a patient with compartment syndrome. Circ J. 2006 Oct;70(10):1362-4. doi: 10.1253/circj.70.1362.
PubMed 16998273Middleton S, Clasper J. Compartment syndrome of the foot--implications for military surgeons. J R Army Med Corps. 2010 Dec;156(4):241-4. doi: 10.1136/jramc-156-04-07.
PubMed 21275358Lenk K, Adams V, Lurz P, Erbs S, Linke A, Gielen S, Schmidt A, Scheinert D, Biamino G, Emmrich F, Schuler G, Hambrecht R. Therapeutical potential of blood-derived progenitor cells in patients with peripheral arterial occlusive disease and critical limb ischaemia. Eur Heart J. 2005 Sep;26(18):1903-9. doi: 10.1093/eurheartj/ehi285. Epub 2005 Apr 26.
PubMed 15855189Melillo E, Ferrari M, Balbarini A, Pedrinelli R. Transcutaneous oxygen and carbon dioxide levels with iloprost administration in diabetic critical limb ischemia. Vasc Endovascular Surg. 2006 Aug-Sep;40(4):303-11. doi: 10.1177/1538574406291824.
PubMed 16959724
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, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma Study Protocol
- ClinicalTrials.gov ID
- NCT01837264
- Acronym / sponsor ID
- Magellan MAR01 / ART-11-003
- Conditions
- Compartment Syndrome
- Keywords
- Magellan MAR01, Autologous Platelet Rich Plasma, Compartment Syndrome, Battlefield Trauma, Fasciotomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Arteriocyte, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 23 Apr 2013 (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.
Compartment syndrome (CS) is a condition resulting from increased pressure within a compartment, which compromises circulation and can lead to critical limb ischemia. CS is one of the biggest medical challenges that our soldiers face after battlefield related injuries. Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute compartment syndrome is a medical emergency requiring surgery. Treatment of compartment syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to evaluate the feasibility and safety of the administration of marrow-derived autologous bone marrow concentrate and PRP gel generated by a point of care marrow separation system for the treatment of compartment syndrome. And to show this treatment possibly enhances wound healing, bone healing, perfusion, infection control, and the return of limb function in patients with CS.
Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and wound healing have predominantly focused on the mechanism of action of a single stem cell population to achieve neovascularization and improve tissue perfusion. It is well documented that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF, bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's development efforts focus on concentration of autologous bone marrow-derived stem cells and platelets for delivery to the site of injury in a concentration sufficient to effect local tissue revascularization and repair. These products provide for the rapid, bedside preparation of autologous PRP and bone marrow stem cell concentrate.
This clinical trial with the Magellan® System is for the preparation of autologous cell concentrate for the treatment of wound, tissue and bone healing, improved perfusion, infection control, and the return of limb function in patients at risk of amputation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Cell Concentrate | Experimental | Device: Magellan® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Is able to provide signed, written informed consent prior to study entry
- Speaks English
- compartment fasciotomy of tibial compartment
- Sufficient skin for primary closure
- Is male or female, 18 - 65 years of age
Key exclusion criteria (11 listed)
- Prior compartment syndrome fracture of same limb
- Previous fracture of the same limb
- Any contraindication to stem cell or platelet-rich plasma therapy.
- Pregnancy
- Have an active malignancy or have undergone treatment for a malignancy in the preceding 5 years, with the exception of successful treatment of non-melanoma skin cancer.
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 |
|---|---|---|
| Magellan®Also: autologous cell concentrate, autologous Bone Marrow Cell Concentrate Using the Magellan® System | Device | Bone Marrow Cell Concentrate |
Primary outcome
Time to treatment failure or death
Time frame: 12 months
* Measurement of rate of infection in the study population * Complications due to wound and/or therapy * Amputation of limb and/or death
1 secondary outcome
Perfusion and quality of life measurements
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Background: PubMed 18376159Ritenour AE, Dorlac WC, Fang R, Woods T, Jenkins DH, Flaherty SF, Wade CE, Holcomb JB. Complications after fasciotomy revision and delayed compartment release in combat patients. J Trauma. 2008 Feb;64(2 Suppl):S153-61; discussion S161-2. doi: 10.1097/TA.0b013e3181607750.
- Background: PubMed 18677497Ateschrang A, Ochs BG, Ludemann M, Weise K, Albrecht D. Fibula and tibia fusion with cancellous allograft vitalised with autologous bone marrow: first results for infected tibial non-union. Arch Orthop Trauma Surg. 2009 Jan;129(1):97-104. doi: 10.1007/s00402-008-0699-2. Epub 2008 Aug 2.
- Background: PubMed 10411974Sebecic B, Gabelica V, Patrlj L, Sosa T. Percutaneous autologous bone marrow grafting on the site of tibial delayed union. Croat Med J. 1999 Sep;40(3):429-32.
- Background: PubMed 16998273Umemura T, Nishioka K, Igarashi A, Kato Y, Ochi M, Chayama K, Yoshizumi M, Higashi Y. Autologous bone marrow mononuclear cell implantation induces angiogenesis and bone regeneration in a patient with compartment syndrome. Circ J. 2006 Oct;70(10):1362-4. doi: 10.1253/circj.70.1362.
- Background: PubMed 21275358Middleton S, Clasper J. Compartment syndrome of the foot--implications for military surgeons. J R Army Med Corps. 2010 Dec;156(4):241-4. doi: 10.1136/jramc-156-04-07.
- Background: PubMed 15855189Lenk K, Adams V, Lurz P, Erbs S, Linke A, Gielen S, Schmidt A, Scheinert D, Biamino G, Emmrich F, Schuler G, Hambrecht R. Therapeutical potential of blood-derived progenitor cells in patients with peripheral arterial occlusive disease and critical limb ischaemia. Eur Heart J. 2005 Sep;26(18):1903-9. doi: 10.1093/eurheartj/ehi285. Epub 2005 Apr 26.
- Background: PubMed 16959724Melillo E, Ferrari M, Balbarini A, Pedrinelli R. Transcutaneous oxygen and carbon dioxide levels with iloprost administration in diabetic critical limb ischemia. Vasc Endovascular Surg. 2006 Aug-Sep;40(4):303-11. doi: 10.1177/1538574406291824.
Related trials for Compartment Syndrome
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Recruiting
Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
Compartment Syndrome Nontraumatic Lower Leg
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
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.
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 Magellan® in people with Compartment Syndrome, run by Arteriocyte, 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 11 inclusion and 11 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: finished, 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to treatment failure or death (time frame: 12 months). 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 NCT01837264, which also lists 7 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.