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

Primary Purpose

Compartment Syndrome

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Magellan®

About this trial

This is an interventional treatment trial for Compartment Syndrome focused on measuring Magellan MAR01, Autologous Platelet Rich Plasma, Compartment Syndrome, Battlefield Trauma, Fasciotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Advocate Christ Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone Marrow Cell Concentrate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01837264

First Posted

April 17, 2013

Last Updated

April 12, 2017

Sponsor

Arteriocyte, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01837264

Brief Title

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

Acronym

Magellan MAR01

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arteriocyte, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Compartment Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bone Marrow Cell Concentrate

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Magellan®

Other Intervention Name(s)

autologous cell concentrate, autologous Bone Marrow Cell Concentrate Using the Magellan® System

Primary Outcome Measure Information:

Title

Time to treatment failure or death

Description

Measurement of rate of infection in the study population Complications due to wound and/or therapy Amputation of limb and/or death

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Perfusion and quality of life measurements

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Barnes, PhD

Organizational Affiliation

Arteriocyte, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Advocate Christ Medical Center

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18376159

Citation

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.

Results Reference

background

PubMed Identifier

18677497

Citation

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.

Results Reference

background

PubMed Identifier

10411974

Citation

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.

Results Reference

background

PubMed Identifier

16998273

Citation

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.

Results Reference

background

PubMed Identifier

21275358

Citation

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.

Results Reference

background

PubMed Identifier

15855189

Citation

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.

Results Reference

background

PubMed Identifier

16959724

Citation

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.

Results Reference

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

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