drugset / Trial / NCT00390767
Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease (PAD)
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2006-10
- Primary completion
- 2010-12
- Completion
- 2024-12
Publications
- Background Staudacher DL, Preis M, Lewis BS, Grossman PM, Flugelman MY. Cellular and molecular therapeutic modalities for arterial obstructive syndromes. Pharmacol Ther. 2006 Jan;109(1-2):263-73. doi: 10.1016/j.pharmthera.2005.08.005. Epub 2005 Oct 21.
- Grossman PM, Mohler ER 3rd, Roessler BJ, Wilensky RL, Levine BL, Woo EY, Upchurch GR Jr, Schneiderman J, Koren B, Hutoran M, Gershstein D, Flugelman MY. Phase I study of multi-gene cell therapy in patients with peripheral artery disease. Vasc Med. 2016 Feb;21(1):21-32. doi: 10.1177/1358863X15612148. Epub 2015 Nov 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MultiGeneAngio | Cell therapy | 1e+07 cells | Other |
| Subject | MultiGeneAngio | Cell therapy | 2e+07 cells | Other |
| Subject | MultiGeneAngio | Cell therapy | 5e+07 cells | Other |
| Subject | MultiGeneAngio | Cell therapy | 7e+07 cells | Other |