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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma Study Protocol

Conditions
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Compartment Syndrome

Intervention / Treatment
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* Device: Magellan®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone Marrow Cell Concentrate<br> | Device: Magellan®<br> <br> * Other names: autologous Bone Marrow Cell Concentrate Using the Magellan® System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magellan MAR01, Autologous Platelet Rich Plasma, Compartment Syndrome, Battlefield Trauma, Fasciotomy