Safety and Preliminary Efficacy of Adipose Derived Stem Cells and Low Frequency Ultrasound in PAD

Completed · Early Phase 1

Conditions studied: Peripheral Arterial Disease

In brief

This is a single center, open label, prospective, randomized, controlled study in patients with non- revascularizable moderate or severe lower extremity Peripheral Arterial Disease (PAD) receiving autologous stem cells therapy (minimally manipulated). This study will enroll a maximum of 10 subjects in this study. The patients will be divided into two groups. One group will receive Adipose Derived Stem Cells (ADSCs) alone and the other group will receive low frequency ultrasound before the addition of ADSCs. The randomization will be 1:1. If the results of this pilot study are not clearly different, there will be a need for a phase II study to support the results. Baseline, 6 week, 3 month and 6 month assessments of 6 min walking distance (6MWT), Ankle Brachial Indexes (ABIs)/Toe Brachial Indexes (TBIs), Transcutaneous Partial Oxygenation (TcPO2) and Rutherford assessments will be performed for the study group. Prior to the stem cell treatment, the ultrasound group patient will receive noninvasive transcutaneous pulsed focused ultrasound around the involved vessel(s) in the affected extremity. All patients will then receive 200 million autologous stromal vascular fraction cells containing adipose derived stem cell therapy: 1/3 of the cells will be delivered intra-venous proximal to the lesion (not retrograde), 1/3 of the cells will be delivered intra- adventitia proximal to the lesion and 1/3 of the cells will be delivered by intra- muscular injection along the vessel path (20-30 injections each separated by1.5 inch). Standard therapy for PAD patients will not be interrupted for the duration of the study. Standard therapy for PAD is defined as cardiovascular general measures like lifestyle changes, smoke cessation, exercise, cardiovascular rehabilitation, etc. All participants have already received maximal non-surgical therapy. Safety will be monitored on an ongoing basis.

Key facts

Study ID: NCT02756884
Run by: Arkansas Heart Hospital
People needed: 10
Starts: 2015-06-03
Expected to finish: 2019-01-31
Last updated by the study team: 2019-06-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males and Females ≥18 years
Patients with a Rutherford classification of 3 or 4.
Non revascularizable lesions by balloon or stent angioplasty of the lower extremity SFA (Superficial femoral artery), Popliteal, AT (anterior tibial), PT (posterior tibial) or peroneal arteries. Non-revascularizable lesions will be determined based on a CT angiogram and/ or angiography.
Life expectancy greater than 6 months.
Ability to understand and provide signed informed consent.
Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits
Written informed consent

You may not qualify if…

Immunosuppressive agents, including but not limited to, corticosteroids and steroidal anti- inflammatory agents (SAIDS)
Non-steroidal anti- inflammatory agents (NSAIDS)
Patients taking currently P2Y12 inhibitors or calcium channel blockers.
Uncontrolled seizure disorder
Dementia
Evidence or presence of immune deficiency.
Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality that in the judgment of the Investigator or Sponsor would pose a safety risk to the subject
Participation in another study with an investigational drug or device within one month prior to treatment
Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study
Inability to comply with the conditions of the protocol.
Allergy to sodium citrate or any "caine" type of local anesthetic

Where it is running

Arkansas Heart Hospital — Little Rock, Arkansas, United States
Arkansas Site Management Services LLC — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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