Frequently Asked Questions
Frequently Asked Questions
Regenerative Medicine is the process of replacing or “regenerating” human cells, tissues, or organs to restore or establish normal function. The process can use tissue from either autologous (you to you) or allogeneic origin (donor to you).
- Autologous: Invasive, sometimes involving a bone punch aspirate to the iliac crest that is potentially very painful and not as rich and potent as placental tissue. Must be used the same day which does not allow for 3rd party testing. Since this material is from the patient, it IS NOT A BIOLOGICALLY YOUNG SOURCE.
- Allogeneic: Non-invasive and no pain involved, provided by FDA regulated tissue banks and manufactured with industry safety guidelines. Because the source is placental in nature, this source IS considered a BIOLOGICALLY YOUNG SOURCE
Our office STRICTLY utilizes PLACENTAL TISSUE derived products. WE DO NOT USE embryonic tissue or embryonic stem cells! Our placental tissue comes from informed, consenting healthy women who give birth via C-section in a clean environment from full-term, live births. The donor’s medical and social history are reviewed and kept on file.
Our product is considered immune-privileged. This means that it cannot and does not trigger the body’s immune response upon injection. Simple language; The injection works or it doesn’t. There are no ill side-effects or after-effects of the treatment.
As always, each patient is case dependent. In some instances, a course of rehabilitation (possibly decompression, laser therapy, exercise, strengthening) can be recommended to help aid in the process of healing.
The HCTP (Human Cell and Tissue Product) we use is cleared/regulated by the FDA under 21 CFR 1271 within a department called the Center for Biologics Evaluation and Research (CBER) and are compliant under section 361 of the public health service act.
This is an in-office procedure and typically takes less than 30 minutes to perform from start to finish. Procedure time will vary from patient to patient.
The material we use in our office is considered a biologic. This biologic is considered Allogeneic (from donor to you) and is derived from minimally manipulated placental tissue, more specifically, the Wharton’s Jelly that is found on the umbilical cord. Within this substance of Wharton’s Jelly, contains billions of Mesenchymal Stem/Stromal Cells (MSCs) that act as the “worker bees” in offering healing and regenerative capabilities to the injured/degenerative area. Along with these MSCs, there is also cytokines, growth factors, hyaluronic acid and various proteoglycans (all help in healing injury, decreasing pain and decreasing inflammation).
Our patients begin to see some sort of change within the first 4-6 weeks. Whether this change is a reduction of pain, reduction of inflammation or an increase of range of motion. Maximum healing time is in the range of 4-6 months, patient and condition dependent.
The injection is performed under image guidance to ensure proper placement of the injected material. Our trained staff is more than happy to show our patients during the procedure either on TVs or iPads the procedure in real time.
With this procedure, there is no downtime per se. Recommendations of a few days rest post procedure is the only “downtime” that could be part of post-procedure care. We encourage our patients to remain active ( on a reasonable level) for about 2-3 weeks post-procedure. After that, full activity levels may resume. As most patient’s are aware, the typical downtime from many surgical procedures varies from 3 weeks to 5 months, depending on procedure.
The procedure is as painful as you would handle any injection. As patient’s pain thresholds vary from person to person, the “pain” associated with this is nominal.