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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Arteriocyte, Inc.
Sponsor:
Information provided by (Responsible Party):
Arteriocyte, Inc.
ClinicalTrials.gov Identifier:
NCT01837264
First received: April 17, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Compartment Syndrome
Device: Magellan®
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma Study Protocol

Resource links provided by NLM:


Further study details as provided by Arteriocyte, Inc.:

Primary Outcome Measures:
  • Time to treatment failure or death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • Measurement of rate of infection in the study population
    • Complications due to wound and/or therapy
    • Amputation of limb and/or death


Secondary Outcome Measures:
  • Perfusion and quality of life measurements [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone Marrow Cell Concentrate Device: Magellan®
Other Names:
  • autologous cell concentrate
  • autologous Bone Marrow Cell Concentrate Using the Magellan® System

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837264

Locations
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Diane Lelo, RN BSN CCRN TNS    708-684-4698    diane.lelo@advocatehealth.com   
Principal Investigator: Eduardo Smith-Singares, MD         
United States, Ohio
Ohio State Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Elizabeth Sheridan-Wagg, MPH, CCRC    614-293-9013    elizabeth.sheridan@osumc.edu   
Contact: Kari Stammen, CCRC    614.366.9138    kari.stammen@osumc.edu   
Principal Investigator: Laura S Phieffer, MD         
Sponsors and Collaborators
Arteriocyte, Inc.
Investigators
Principal Investigator: Laura S Phieffer, MD The Ohio State University College of Medicine Department of Orthopaedics
  More Information

Publications:

Responsible Party: Arteriocyte, Inc.
ClinicalTrials.gov Identifier: NCT01837264     History of Changes
Other Study ID Numbers: ART-11-003
Study First Received: April 17, 2013
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Arteriocyte, Inc.:
Magellan MAR01
Autologous Platelet Rich Plasma
Compartment Syndrome
Battlefield Trauma
Fasciotomy

Additional relevant MeSH terms:
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014