Status:
COMPLETED
Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma
Lead Sponsor:
Arteriocyte, Inc.
Conditions:
Compartment Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01837264
Start Date
January 1 2013
End Date
January 31 2017
Last Update
April 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453