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

Arteriocyte Medical Systems

Status and phase

Completed

Phase 1

Conditions

Compartment Syndrome

Treatments

Device: Magellan®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01837264

ART-11-003

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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