Are Stem Cells approved by the FDA?
No, all procedures at iOBX™ use stem cells from your own body and fall under the following exemptions
Treatments involving the removal of an HCT/P from a patient and the implantation of that same HCT/P back into the same patient during the same surgical procedure are not subject to FDA regulation; 21 CFR 1271.15(b).
For treatments involving premium bone marrow, minimally manipulated for homologous use is not subject to FDA regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P); 21 CFR 1271.3(d).
For our procedures involving autologous blood (ie: PRP), practitioners who are licensed by law to prescribe or administer drugs and who manufacture blood products solely for use in the course of their professional practice are not subject to FDA regulation; 21 CFR 607.65.
All procedures at iOBX™ adhere to a stringent level of cleanliness and sterility. We process stem cells from bone marrow and fat tissue utilizing FDA compliant guidelines. The safety standards, focus on patients, and scientific expertise provided by the Advanced Onsite Orthopedic Biologics Laboratory at iOBX™️ make for a unique and outstanding patient experience.