Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia

NCT02099500 | Withdrawn Phase 1

• 1 other identifier: ADI-US-CLIN-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for revascularization. The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for intramuscular injection into the lower limb.

Conditions

Critical Limb Ischemia

Keywords

Critical Limb Ischemia; Peripheral Vascular Disease; Lower Limb Ulcer; Gangrene; Amputation; Lower Limb Wound

Outcome Measures

Primary Outcomes (2)

• Improvement from baseline in perfusion as measured by ankle-brachial index and collateral artery number

  Contrast Angiography

  6 months

• Number of adverse events reported

  6 months

Secondary Outcomes (2)

• Improvement from baseline in improvement or resolution of ulcer or gangrene

  3 months, 6 months

• Limb Salvage

  3 months and 6 months

Other Outcomes (1)

• Change from baseline in Quality of Life

  3 months, 6 months

Study Arms (1)

Stem Cell Injection

EXPERIMENTAL

Non-Randomized

Procedure: Liposuction; Other: Stem Cell Injection

Interventions

Liposuction PROCEDURE

Liposuction using aspiration syringe and tumescent local anesthesia

Also known as: Adipose-Derived Stem Cells

Stem Cell Injection

Stem Cell Injection OTHER

Stem cell implantation will be performed using intramuscular injection into the affected ischemic site of interest

Stem Cell Injection

Eligibility Criteria

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

You may qualify if:

• Age \~ 18 years
• Existence of limb ischemia, with clinical presentation corresponding to Rutherford Categories 2-6 as defined in the reporting standards adopted by \\ the Society of Vascular Surgeons, or corresponding to the Leriche-Fontaine Classification, stages II, III, or IV
• Patients with, ischemia and ischemic ulceration provided patient have angiographic evidence of vascular compromise and is not a candidate for revascularization
• Stable and on optimal medical management for \> 60 days as follows:
• Clopidogrel/aspirin therapy or other anticoagulation therapy, cholesterol- lowering agent, and⁄or antihypertensive medication
• Hematocrit ≥ 28.0%, White Blood Cell count ≤14,000, Platelet count ≥ 50,000
• Creatinine ≤ 2.5 mg/dL, and INR ≤ 1.6 (unless taking warfarin) or PTT \< 1.5× control (to avoid bleeding complications). INR values for patients taking warfarin will be corrected prior to the procedure
• Patient meets at least one of the following diagnostic criteria for the index limb:
• ABI\<.5mmHg
• TcpO2 \<20 mm Hg when lying down and breathing room air, if available
• Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization
• At least one non-healing distal extremity ischemic ulcer as confirmed by a vascular surgeon
• Up to date on all age and gender appropriate cancer screening per American Cancer Society

You may not qualify if:

• Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception
• Any medical problems contraindicating tumescent syringe liposuction
• Life expectancy \< 6 months
• Patient determined to be nonsurgical candidate due to reasons such as
• High-risk medical conditions
• Unstable cardiac disease
• Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to the initial screening visit
• Severe arthritis or other musculoskeletal disorder.
• Systolic blood pressure (supine) ≤ 90 mmHg
• Resting heart rate \> 100 bpm
• Poorly controlled diabetes mellitus (HgbA1c \> 10%)
• Life-threatening complications of limb ischemia necessitating immediate amputation
• Uncorrected iliac artery occlusion on index side unless corrected with stent
• Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
• Active clinical infection within one week of enrollment

Sponsors & Collaborators

• Ageless Regenerative Institute: lead

Study Sites (1)

Ageless Institute

Miami, Florida, 33180, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Leg Ulcer; Gangrene

Interventions

Lipectomy

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; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Necrosis

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Sharon McQuillan, MD

  Ageless Regenerative Institute

  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: March 19, 2014
• First Posted: March 31, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)