Advancing Medical Knowledge
Saul was a widower who had Critical Limb Ischemia (CLI) with pain at rest. His doctor told him he needed amputation. Saul's son, a physician, found our program. Stem cell treatment ensured Saul avoided amputation and gave him far better quality of life for more 9 years, until he passed away.
Dave is a Lobster fisherman and doctors told him that he needed an immediate left above knee amputation for Peripheral Artery Disease. Dave wanted to save his leg long enough for his son to return home from Iraq. After participating in our stem cell trial, Dave was able to postpone his amputation for more than…
Maria is a 23 year old single mother with auto-immune vascular disease. She was ineligible for a bypass or angioplasty and prescribed methadone (an opioid to relieve severe pain) for pain at-rest. After stem cell therapy, Maria's pain was relieved and she no longer needed methadone for pain management.
WHAT IS A TRIAL?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies. ClinicalTrials.gov includes both interventional and observational studies.
Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).
This material is provided by ClinicalTrials.gov
Clinical Research Phase Studies
While preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. “Clinical research” refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins.
Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.
- Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
- Length of Study: Several months
- Purpose: Safety and dosage Approximately 70% of drugs move to the next phase
- Study Participants: Up to several hundred people with the disease/condition.
- Length of Study: Several months to 2 years
- Purpose: Efficacy and side effects
Approximately 33% of drugs move to the next phase
- Study Participants: 300 to 3,000 volunteers who have the disease or condition
- Length of Study: 1 to 4 years
- Purpose: Efficacy and monitoring of adverse reactions
Approximately 25-30% of drugs move to the next phase
- Study Participants: Several thousand volunteers who have the disease/condition
- Purpose: Safety and efficacy