Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia

NCT02234778 | Unknown

• 1 other identifier: TGI-002-01-2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device removes certain cells from the adipose (fat) tissue which will be used to treat patients with blockages in the arteries of their lower legs that may require a future amputation, which is caused by severe peripheral artery disease (PAD). The purpose of this study is to determine if treatment with cells that have been removed from the Icellator System™ device will reduce the number of major amputations and deaths in a six month time period.

Conditions

Critical Limb Ischemia

Keywords

critical limb ischemia; autologous stromal vascular fraction

Outcome Measures

Primary Outcomes (1)

• Amputation-Free Survival

  To obtain preliminary feasibility evidence of the ability of the Tissue Genesis Inc. (TGI) stromal vascular fraction (SVF) material to result in freedom from major amputation (above the ankle) or death at 26 weeks following treatment. Treatment failure is defined as the composite of major amputation of the treatment limb or all-cause death.

  26 weeks

Study Arms (1)

Study Treatment

EXPERIMENTAL

Each subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. TGI SVF material injection will be completed within 4 hours of cell separation.

Device: TGI SVF material via intramuscular injection

Interventions

TGI SVF material via intramuscular injection DEVICE

Each SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period.

Study Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critical limb ischemia (CLI), defined as ischemic pain at rest (Rutherford Category 4) or minor tissue loss of the limb (Rutherford Category 5), and with either toe artery occlusive pressure \< 50 mmHg or TBI ≤ 0.5 or ankle artery occlusion pressure ≤ 60 mm Hg or ABI ≤ 0.5
• No reasonable open or endovascular surgical options as determined by treating vascular specialist
• Competent to give consent
• Age 21 years or greater
• Females of child bearing potential agree to use acceptable methods of contraception for the duration of the trial. Sexually active males agree to use an accepted and effective method of contraception for the duration of the trial.
• All diabetic subjects will undergo baseline and 12-month follow-up retinal examinations conducted by a specialist
• No current malignancy or history of previous malignancy within the last five years, with the exception of adequately treated non-melanoma cutaneous carcinoma (basal cell or squamous cell carcinoma of the skin).

You may not qualify if:

• Major tissue loss of the index limb (Rutherford Category 6)
• Limb revascularization surgery within 45 days of enrollment in this study
• Subjects with less than 15% body fat as measured by calipers or electrical impedance
• Subjects with less than a 2 cm x 2 cm roll of subcutaneous abdominal fat, when pinched between the examiner's fingers, while the subject is in a supine position
• Poorly controlled diabetes mellitus evidenced by HbA1C \> 10%. Diabetic subjects must have evidence of a glycosylated hemoglobin test (HbA1C) performed within the last 30 days.
• Uncompensated congestive heart failure (New York Heart Association Class IV) and/or other conditions that preclude general anesthesia.
• Myocardial infarction or stroke within the last 90 days.
• Elevated liver function tests (AST or ALT more than twice the upper limit of normal).
• Hematologic abnormalities.
• Disease of the central nervous system and/or other conditions that impair cognitive function.
• History of two or more episodes of pulmonary embolus with a documented deep venous thrombosis (DVT) (Duplex US or venography) in the index extremity or history of DVT in the index extremity without evidence of clot resolution (Duplex US or venography)
• Infection of the index leg
• Pregnant or lactating females. Prior to enrollment, women of child-bearing potential must have a negative urine pregnancy test.
• Lower extremity venous disease or lymphedema with pitting edema in the index leg
• Osteomyelitis in the index leg

Sponsors & Collaborators

• Tissue Genesis: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

US (1)