What is a clinical study?
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.
All Translational Biosciences-sponsored clinical studies are listed on ClinicalTrials.gov
What happens in a clinical trial?
In clinical trials, investigational drugs are tested for safety and efficacy. Clinical trials often compare the investigation drug with currently-approved drugs and/or placebo (inactive pill, liquid or powder).
In our clinical trials, participants may be assigned to take:
- Human umbilical cord-derived mesenchymal stem cells (huMSC)
- Mesenchymal trophic factors derived from huMSC
- Autologous stromal vascular fraction (SVF) derived from adipose tissue (fat)
- autologous bone marrow-derived mononuclear cells (BMMC)
These products may be given:
- Intravenously (into a vein)
- Intrathecally (into the spinal canal)
- Intra-articularly (into a joint)
- Subcutaneously (under the skin)
How are clinical trials organized?
Clinical trials are organized into four phases:
Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Who can participate in clinical trials?
Participants must meet certain criteria in order to be eligible to participate in a clinical trial. These requirements are formally called inclusion criteria and exclusion criteria. Typical requirements are type and stage of disease, previous treatments, age, gender, and other medical conditions. Participation in clinical trials does not require medical insurance.
Before anyone can participate in a clinical trial, he or she will be asked to sign an informed consent document. The informed consent document includes information about the clinical trial including potential benefits and risks associated with the research.
Participants should read this document carefully and be sure to ask questions about anything they don’t understand. The informed consent must be signed once the participant is satisfied that all of his or her questions have been answered.
What are the possible benefits and risks of clinical trials?
According to the National Institutes of Health, potential benefits include:
- Gaining access to new treatments before they are widely available
- Being one of the first to benefit from a new treatment
- Helping others by adding to the current body of scientific knowledge
According to the NIH, possible risks include:
- The new treatment might not work.
- There could be adverse side-effects or other unknown risks. This is especially true in phase 1 and phase 2 trials.
- Health insurance and health care providers don’t always cover all patient costs for clinical trials
Who oversees Translational Bioscience’s clinical trials?
Our clinical trials are approved and monitored by Comité Nacional de Bioética de la Investigación Institutional Review Board (IRB) .
What should I ask the doctor before I decide to participate?
*All of these questions and more will be answered when you read the informed consent document.
Why are you conducting this clinical trial?
How long will this trial last?
How many times will I have to go to the clinic or hospital?
What tests and procedures are involved?
Will some participants be receiving a placebo?
What are the benefits and risks involved?
How will you be following my progress?
Will my medical information be kept confidential?