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Clinical Trial Information for Physicians

The information below is intended for Physicians only. If you have any questions, please call 855.333.3260 or email cvtrials@iupui.edu

The PACE Study Key Points for healthcare professionals

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Study Design and Purpose

The PACE study randomizes subjects in a 1:1 ratio to receive either ALDHbr cells or placebo, by intramuscular injection into the affected leg. Commitment to the sutdy involves eight study visits over a six month period and a phone call at twelve months. Study participants continue to be followed by their routine care providers during study participation.

Primary and Secondary Endpoints

Secondary endpoints include change over time of: pre and post-exercise ABI, claudication onset time, peak walking time at three months and patient perception of walking impairment as well as other peripheral artery disease symptoms.

To qualify for PACE

Patients must be over the ave of 40 with intermitten claudication and ABI <.90. Qualified candidates will carry a confirmed diagnosis of PAD and have >50% stenosis of at least one artery amont the superficial femoral, popliteal and/or infrapopliteal arteries. This stenosis may be determined by Duplex ultrasound, lower extremity CTA, lower extremity MRA, or lower extremity catheter-based contrast arteriography.

Study treatment procedure

All subjects undergo bone marrow harvest. This is an outpatient procedure, and is performed in a hospital operating room setting with the use of conscious sedation. The bone marrow is transported to a facility in Houston, Texas for processing. Approximately two days after the bone marrow harvest, the subject returns for injections of either placebo of ADLHbr cells. A total of ten intramuscular injections are delivered into the more symptomatic lower limb. Study procedures are provided at no cost to the subject and a study stipend is available to assist with travel expenses.

Study Sponsor

The PACE Study is being conducted through teh Cardiovascular Cell Therapy Research Network (CCRTN) and is sponsored by the National Heart Lunk Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Study Sites

Study sites include locations in Indiana, Kentucky, Florida, Minnesota, Texas and California. Contact us to learn more.

This study is conducted by researchers in the Indiana School of Medicine. For more information or to determine qualification for the study, contact us at cvtrials@iupui.edu or 855.333.3260.

To learn more about the Indiana Center for Vascular Biology and Medicine at the IU School of Medicine, visit http://vascularbiomed.medicine.iu.edu

TGAIT Study Key Points for healthcare professionals

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Study Design and Purpose

The TGAIT Study is evaluating an investigational treatment for critical limb ischemia (CLI) caused by peripheral artery disease (PAD). The treatment involves a device called the Icellator Cell Isolation SystemTM which processes a patient's own adipose tissue (harvested from a minimally invasive liposuction of around 100 cc) to obtain a preparation rich in adipose-derived stem and progenitor cells that can be used in an attempt to restore blood flow and rescue the affected leg and foot from ischemia. The stem/progenitor cell preparation is available from the fat within less than 80 minutes, and is used at the point of care.

The protocal takes about three hours. After the procedure, there are five in-person follow-up visits and one follow-up telephoen call during the course of approximately six months. Study procedures are provided at no cost to the subject.

Primary Endpoints

Time to treatment failure, with "treatment failure" defined as the composite of major amputation of the study limb or all cause death (Amputation Free Survival). The primary endpoint for initial safety is adverse events considered potentially related to the study treatment through 26 weeks post-procedure.

To Qualify for TGAIT

Critical limb ischemia (CLI), defined as rest pain (Rutherford Category 4), or minor tissue loss of the limg (Rutherford Category 5), and with either:

No reasonable open/endovascular surgical options

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)

Prior to enrollment, subjects meeting the sex/age criteria below must undergo a cancer screening and have corresponding evidence of the following:

  1. if > 50 years of age (male or female), a colonoscopy or fecal occult blood test negative for cancer, performed within the last year
  2. for males > 45 years of age, a prostate specific antigen (PSA) test negative for cancer, performed within the last two years
  3. for females > 40 years of age, a mammogram negative for cancer, performed within the last two years
  4. for females of any age, a Papanicolaou (pap) smear negative for cancer, performed within the last two years

Age 21 years or greater and competent to give consent

Females of child bearing potential agree to use acceptable methods of contraception for duration of the trial. Sexually active males agree to use an accepted and effective method of contraception for the duration of the trial

Study Sponsor

The TGAIT study is being conducted through Tissue Genesis, Inc., with a funding sponsor of the US Army Medican Research and Materiel Command, Telemedicine & Advanced Technology Research Center.

This study is conducted by researchers in the Indiana University School of Medicine. For more information or to determine qualification for the study, contact us at cvtrials@iupui.edu or 855.333.3260.

To learn more about the Indiana Center for Vascular Biology and Medicine at the IU School of Medicine, visit http://vascularbiomed.medicine.iu.edu

 

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