ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02099500
Recruitment Status : Withdrawn (no participants enrolled)
First Posted : March 31, 2014
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ageless Regenerative Institute

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.


Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Procedure: Liposuction Other: Stem Cell Injection Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Non-Randomized, Patient Funded, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
Study Start Date : March 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Stem Cell Injection
Non-Randomized
Procedure: Liposuction
Liposuction using aspiration syringe and tumescent local anesthesia
Other Name: Adipose-Derived Stem Cells

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




Primary Outcome Measures :
  1. Improvement from baseline in perfusion as measured by ankle-brachial index and collateral artery number [ Time Frame: 6 months ]
    Contrast Angiography

  2. Number of adverse events reported [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Improvement from baseline in improvement or resolution of ulcer or gangrene [ Time Frame: 3 months, 6 months ]
    Visual assessment

  2. Limb Salvage [ Time Frame: 3 months and 6 months ]
    Assessed with doppler to measure blood flow to the affected area.


Other Outcome Measures:
  1. Change from baseline in Quality of Life [ Time Frame: 3 months, 6 months ]
    King's College Hospital's Vascular Quality of Life Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. ABI<.5mmHg
    2. TcpO2 <20 mm Hg when lying down and breathing room air, if available
    3. 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

Exclusion Criteria:

  • 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

    1. High-risk medical conditions
    2. Unstable cardiac disease
    3. Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to the initial screening visit
    4. 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
  • Treatment with immunosuppressant drugs
  • Known drug or alcohol dependence, or any other factors which will interfere with the study conduct or interpretation of the results
  • Not suitable to participate in the opinion of the principal investigator
  • History cancer (other than non-melanoma skin cancer or in situ cervical cancer) within five years preceding study entry
  • Unwilling and/or not able to give written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099500


Locations
United States, Florida
Ageless Institute
Miami, Florida, United States, 33180
Sponsors and Collaborators
Ageless Regenerative Institute
Investigators
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT02099500     History of Changes
Other Study ID Numbers: ADI-US-CLIN-001
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ageless Regenerative Institute:
Critical Limb Ischemia
Peripheral Vascular Disease
Lower Limb Ulcer
Gangrene
Amputation
Lower Limb Wound

Additional relevant MeSH terms:
Ischemia
Pathologic Processes