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NCT02756884 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Preliminary Efficacy of Adipose Derived Stem Cells and Low Frequency Ultrasound in PAD
A Early Phase 1 study of Peripheral Arterial Disease, sponsored by Arkansas Heart Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT02756884: Completed Early Phase 1 study of Peripheral Arterial Disease, sponsored by Arkansas Heart Hospital.
NCT02756884 is a Early Phase 1 study of Peripheral Arterial Disease that has completed, run by Arkansas Heart Hospital. The registered enrollment target is 10 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02756884, a Early Phase 1 study of Peripheral Arterial Disease, has completed, sponsored by Arkansas Heart Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
The primary outcome will be the safety/tolerability of treatment with aADSC in patients with PAD as determined by the incidence and severity of adverse events and serious adverse events.
Conditions Studied
Interventions
- BIOLOGICAL LoFU and aADSC
- BIOLOGICAL adipose derived stem cells
Study Locations (2)
Arkansas
- Arkansas Heart Hospital - Little Rock
- Arkansas Site Management Services LLC - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-06-03 |
| Est. Completion | 2019-01-31 |
| Phase | Early Phase 1 |
What the finished NCT02756884 record still lists
NCT02756884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which LoFU and aADSC is the first listed.
NCT02756884 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT02756884 about?
NCT02756884 is a clinical study titled "Safety and Preliminary Efficacy of Adipose Derived Stem Cells and Low Frequency Ultrasound in PAD". 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 ...
What is the current status of trial NCT02756884?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2015-06-03. Estimated completion is 2019-01-31.
What conditions does trial NCT02756884 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT02756884?
The interventions under investigation include: LoFU and aADSC (BIOLOGICAL), adipose derived stem cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02756884?
This trial is sponsored by Arkansas Heart Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02756884 being conducted?
This trial has 2 study locations across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02756884's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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