Institutional Review Board, Hospital for Special Surgery
November 22, 2011
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
The study seeks to learn and examine the feasibility of using new techniques to assess the biological composition of platelet rich plasma, such as mass spectrometry, flow cytometry and blood smears.
Information about the biology of PRP therapy will help to inform future studies analyzing the potential clinical effects of PRPs on soft tissue and cartilage healing.
Blood from 20 healthy volunteers will be withdrawn at one time point only. There will be no intervention or follow up associated with this study. Consent will be obtained at the time of initial enrollment. Enrollment will conclude when 20 healthy individuals have been enrolled.
Inclusion Criteria
• The following study cohort will be included:
• Ages 18 to 75
• The subject is willing and able to comply with the consent process, and does not feel any pressure to volunteer
Exclusion Criteria
• Patients will be excluded if they do not fall within the predetermined age range
• Prior history of PRP therapy
• The subject is unable or unwilling to provide informed consent or feels obligated to participate in the study.
• Patient is regularly taking NSAIDs or anti-platelet medications
• Medical comorbidities including (1) inflammatory arthropathies, (2) active malignancy, (3) septicemia or (4) receiving dialysis or immunosuppressive therapy
• The subject has a history of bleeding diatheses or coagulopathy, or suffered from a hemorrhagic stroke < 6 months prior to the study procedure.
• The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), HIV/AIDS or any autoimmune diseases at the time of study procedure.
Salma Chaudhury,MD,PhD
chaudhurys@hss.edu
212.555.2520
914.953.0015