NCT02756884

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

Completed EARLY_PHASE1 Last updated 26 June 2019

What this trial tests

EARLY_PHASE1 trial testing LoFU and aADSC in Peripheral Arterial Disease in 10 participants. Completed in 31 January 2019.

Timeline

3 June 2015

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Arkansas Heart Hospital
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	3 June 2015
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	2 locations across United States

Drugs / interventions tested

• LoFU and aADSC — full drug profile →
• adipose derived stem cells — full drug profile →

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Arkansas Heart Hospital

Who can join

Adults 18 to 99, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic angiogenesis of adipose-derived stem cells for ischemic diseases.
   Zhao L, Johnson T, Liu D. · · 2017 · cited 137× · PMID 28583178 · DOI 10.1186/s13287-017-0578-2
2. Concise Review: Fat and Furious: Harnessing the Full Potential of Adipose-Derived Stromal Vascular Fraction.
   Dykstra JA, Facile T, Patrick RJ, Francis KR, et al · · 2017 · cited 77× · PMID 28186685 · DOI 10.1002/sctm.16-0337
3. Adipose-Derived Mesenchymal Stromal Cells in Basic Research and Clinical Applications.
   Czerwiec K, Zawrzykraj M, Deptuła M, Skoniecka A, et al · · 2023 · cited 53× · PMID 36835295 · DOI 10.3390/ijms24043888
4. Acoustic Radiation or Cavitation Forces From Therapeutic Ultrasound Generate Prostaglandins and Increase Mesenchymal Stromal Cell Homing to Murine Muscle.
   Lorsung RM, Rosenblatt RB, Cohen G, Frank JA, et al · · 2020 · cited 12× · PMID 32850728 · DOI 10.3389/fbioe.2020.00870
5. Bioengineering Cell Therapy for Treatment of Peripheral Artery Disease.
   Huang NF, Stern B, Oropeza BP, Zaitseva TS, et al · · 2024 · cited 5× · PMID 38174560 · DOI 10.1161/atvbaha.123.318126
6. Stem Cells in Cardiovascular Medicine: the Road to Regenerative Therapies.
   Anderson CW, Boardman N, Luo J, Park J, et al · · 2017 · cited 3× · PMID 28324469 · DOI 10.1007/s11886-017-0841-2