Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)

NCT01386216 | Completed Phase 1 DMC

• 1 other identifier: ART 10-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).

Conditions

Critical Limb Ischemia (CLI); Peripheral Vascular Disease (PVD)

Keywords

Critical limb ischemia; Peripheral vascular disease; platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure or death

  Treatment failure is defined as major amputation

  Baseline - 12 months

Secondary Outcomes (1)

• Perfusion and Quality of Life measurements

  Baseline - 12 months

Study Arms (1)

Bone Marrow Cell Concentrate

EXPERIMENTAL

Bone Marrow Cell Concentrate Prepared Using the Magellan System

Device: Magellan®

Interventions

Magellan® DEVICE

Autologous Bone Marrow Cell Concentrate Prepared Using the Magellan System to be injected into the ischemic muscle tissue at 0.5 cc/injection for a total of 12-20 cc.

Also known as: autologous cell concentrate

Bone Marrow Cell Concentrate

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is able to provide written informed consent prior to study entry
• Is male or female, 18 - 85 years of age
• CLI with rest pain, tissue loss, or gangrene
• No option for revascularization as a result of one of the following:
• failed previous revascularization, such as recurrent instant restenosis or graft occlusion.
• inadequate target vessels as determined by baseline CTA/angiogram at the time of enrollment.
• or prohibitive medical comorbidities such as high risk cardiovascular or pulmonary disease which would restrict operative procedures
• Final determination of no option for revascularization will be made by a vascular surgeon not associated with the clinical trial.
• ABI less than 0.7, ankle pressure \< 50 mmHg, or toe pressure \< 30 mmHg.
• TcPO2 \< 40 mmHg
• SPP \< 35 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,

You may not qualify if:

• Patients with vascular lesions amenable to percutaneous intervention or where surgical bypass is indicated.
• Any contraindication to stem cell or platelet-rich plasma therapy.
• Isolated aorto-iliac stenoses or occlusions without infra-inguinal disease.
• Pregnancy
• Hemoglobin A1c \>10 % on day of enrollment.
• 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)
• Hemoglobin \< 10 g/dl.
• Thrombocytopenia \< 100,000 platelets/µL.
• Unwilling or unable to comply with follow-up visits.
• Proliferative retinopathy as determined by baseline retinal exam.
• 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

Sponsors & Collaborators

• Arteriocyte, Inc.: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Michael Go, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

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: June 29, 2011
• First Posted: July 1, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)