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

NCT01837264 | Completed Phase 1 DMC

• 1 other identifier: ART-11-003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Magellan MAR01; Autologous Platelet Rich Plasma; Compartment Syndrome; Battlefield Trauma; Fasciotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Perfusion and quality of life measurements

  12 months

Study Arms (1)

Bone Marrow Cell Concentrate

EXPERIMENTAL

Device: Magellan®

Interventions

Magellan® DEVICE

Also known as: autologous cell concentrate, autologous Bone Marrow Cell Concentrate Using the Magellan® System

Bone Marrow Cell Concentrate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arteriocyte, Inc.: lead

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Related Publications (7)

• 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.

  PMID: 18376159 BACKGROUND

• Ateschrang 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.

  PMID: 18677497 BACKGROUND

• Sebecic 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.

  PMID: 10411974 BACKGROUND

• Umemura 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.

  PMID: 16998273 BACKGROUND

• Middleton 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.

  PMID: 21275358 BACKGROUND

• Lenk 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.

  PMID: 15855189 BACKGROUND

• Melillo 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.

  PMID: 16959724 BACKGROUND

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brian Barnes, PhD

  Arteriocyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 23, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: January 31, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-01

Locations

US (1)