Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma (Magellan MAR01)

April 12, 2017 updated by: Arteriocyte, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bone Marrow Cell Concentrate
Device: Magellan®
Other Names:
  • autologous cell concentrate
  • autologous Bone Marrow Cell Concentrate Using the Magellan® System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perfusion and quality of life measurements
Time Frame: 12 months

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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arteriocyte, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Brian Barnes, PhD, Arteriocyte, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ART-11-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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