NCT00390767

A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease

Status unknown Phase 1/Phase 2 Last updated 4 March 2015

What this trial tests

Phase 1/Phase 2 trial testing MultiGeneAngio in PAD in 12 participants. Status unknown.

Timeline

1 October 2006

Primary endpoint
1 December 2010

1 December 2024

Quick facts

Lead sponsor	MultiGene Vascular Systems Ltd.
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 October 2006
Primary completion	1 December 2010
Estimated completion	1 December 2024
Sites	2 locations across United States

Drugs / interventions tested

• MultiGeneAngio — full drug profile →

Conditions studied

• PAD — all drugs for PAD →
• Claudication — all drugs for Claudication →

Sponsor

MultiGene Vascular Systems Ltd. — full company profile →

Who can join

Adults 50 to 80, any sex, with PAD or Claudication. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The safety of MultiGeneAngio will be assessed by monitoring adverse events
  Time frame: Up to 15 years after treatment

Sponsor's own description

The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease.

Publications & conference data

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

1. Angiogenic gene therapy in cardiovascular diseases: dream or vision?
   Ylä-Herttuala S, Bridges C, Katz MG, Korpisalo P. · · 2017 · cited 135× · PMID 28073865 · DOI 10.1093/eurheartj/ehw547
2. Phase I study of multi-gene cell therapy in patients with peripheral artery disease.
   Grossman PM, Mohler ER, Roessler BJ, Wilensky RL, et al · · 2016 · cited 9× · PMID 26584888 · DOI 10.1177/1358863x15612148
3. 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
4. Combination stem cell therapy using dental pulp stem cells and human umbilical vein endothelial cells for critical hindlimb ischemia.
   Kim CK, Hwang JY, Hong TH, Lee DM, et al · · 2022 · cited 3× · PMID 35168701
5. Mendel Symposium II: Genes and the Heart, Joint Meeting of the Japan and European Sections of the International Academy of Cardiovascular Sciences, September 24 to 27, 2008, Leblice, Czech Republic
   Briest W, Muller G, Cooper T, Krawczyk M, et al · · 2008