Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/14/2017 |
| Start Date: | January 2013 |
| End Date: | June 2017 |
Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma Study Protocol
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.
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.
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
We found this trial at
1
site
Advocate Christ Medical Center Advocate Health Care, named among the nation
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