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Peripheral Artery Disease - Healing Genes
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Peripheral Artery Disease

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Hepatocyte Growth Factor to Improve Functioning in PAD (HI-PAD)

Hepatocyte Growth Factor to Improve Functioning in Peripheral Artery Disease: The HI-PAD Study


Phase 3

DESCRIPTION:

Northwestern University researchers are seeking 39 people with peripheral artery disease (PAD) who do not have critical limb ischemia for an investigatory therapy. The VM202 therapy is a loop of DNA, or plasmid, that encodes for hepatocyte growth factor (HGF) which has neurotrophic and angiogenic properties. By prompting cells to take in this DNA and express the growth factor, repairing the nerves and promoting arterial growth in the ischemic limb, the treatment aims to reduce pain, improve mobility, and observe muscle regeneration.

The investigatory drug is injected in calf skeletal muscle every 14 days for a total of four treatment days; however, a portion of participants will receive a placebo injection.


PATIENT MUST:

  • Be 55 years of age or older
  • Have symptomatic PAD meeting clinical criteria of the study
  • Not have above- or below-knee amputation or critical limb ischemia, including individuals with gangrene and lower extremity ulcers
  • Not be wheelchair-bound or requiring a cane or walker to ambulate

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Administration of VM202, then additional injections of VM202 at 2 weeks, 4 weeks, and 6 weeks.
  3. Follow up continues at 3 and 6 months.

LOCATIONS AND CONTACTS:

The study will be taking place at Northwestern University in Chicago, IL. Map.

 

Contacts:

Contact: Mary McDermott, MD  |  312-503-6419  |  [email protected]

Contact: Kathryn Domanchuk, BS  |  312-503-6438  |  [email protected]

 

SPONSOR INFORMATION:

Northwestern University

National Institute on Aging (NIA)

Helixmith Co., Ltd.

 

Or go online:

https://clinicaltrials.gov/show/NCT03363165

 

 

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