FDA Clinical Trials (In Conjunction with IRBs)
Clinical trials are recorded with the FDA and are intended to study the safety and efficiency of treatments, medication (drug trials), and are provided an NCT Number which expands and explains the nature and content of the trials. By going to www.clinicaltrials.gov anyone can visit, type in the NCT Number and read all about the studies. This includes information on the reason for the study, as well as information regarding its nature, and who may be included (or excluded).
“IRB” is a term commonly used to describe an oversight body, an Investigational Review Board (IRB). This is comprised of knowledgeable, experienced clinicians and researchers who review the content and nature of the studies to be submitted to the FDA body. This is an important step to protect patients and providers to review and help track the outcomes and safety of any human clinical research effort.
There are types of trials in which large drug companies sponsor (with intent of patent protection) and those which are Foundation, Grant, or Equipment providers. Some of these types of clinical trials deal with advancing clinical science and information, any may be partial funding sources. Others are partially sponsored, i.e. supplies, very expensive equipment to permit needed functions for the trial, testing equipment, etc., with some patient contribution to enter and defray some of the costs to have the treatment. In our case, there is no additional funding from patients devoted to the Principal Investigator (physician fees), reflected in the markedly reduced fees due from the individual patient.
Below are specific trials which are currently underway in GARM-USA system. An addition trial focused on musculoskeletal, spine, and pain issues within Orthopedic Medicine is currently in review.
Go to Clinicaltrials.gov website. Enter the NCT Numbers shown below in order to gain detail about each study. You may return to this site to make an inquiry (www.GARM-USA.com) or contact us via email [email protected] for more information and to ask questions via our Contact Us section.
- NCT02939859 Adipose-Derived Cellular Stromal Vascular Fraction in Autoimmune, Inflammatory, Neurologic Conditions
- NCT02961114 Use of Autologous Adipose-Derived Stem Stromal Cells in Benign Prostate Hypertrophy (BPH)
- NCT02952131 Use of Autologous Adult Adipose Derived Stem Stromal Cells in Inflammatory Bowel Disease (IBD)
- NCT02946658 Use of Autologous Adult Adipose Derived Stem Stromal Cells in Chronic Lung Disorders (COPD, Asthma, Fibrotic Lung
- NCT02959294 Use of Adipose-Derived Stem Stromal Cells in Concussion and Traumatic Brain Injuries (TBI, Concussion)
- NCT02987855 Adipose Stem Stromal Cells in RSD, CRPS, Fibromyalgia
- NCT02849470 AGA Biocellular Stem Stromal Cells Hair Regenerative Study (STRAAND)