FREQUENTLY ASKED QUESTIONS (FAQs)
1. How are Stem Cells Collected?
In some patients, we are able to utilize the patients own bone marrow. In some other, we use the very best and proven product available by Predicitve Biotech. All human cells are processed from donated tissue from full term deliveries and are regulated as a human cell, tissue, or tissue-based or cellular product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.
Each donor is thoroughly evaluated, detailed medical and social backgrounds are obtained and tissues are procured, processed, and tested according to FDA requirements to minimize possible risks of disease transmission to recipients.
Infectious disease testing is carried out at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1998 (CLIA) and 42 CFR part 493.
2. Has this been FDA approved?
With increasingly more press coverage highlighting Regenerative Medicine, there is more inaccurate information and more myths to be exposed. We pride ourselves on keeping up to date with the most recent FDA Regulations and Guidance for Regenerative Medicine as this field continues to grow and we continue to learn more about the power of this particular approach to healthcare.
Currently, the FDA regulates how the cells are processed, stored, and tested to guard patient safety and minimize the risk of any type of disease transmission. The FDA; “approves” pharmaceuticals and; “clears” medical devices for safety. Currently, these cells do not fall into either category.
3. How many treatments will I need?
You are an individual. Your case history and current health are as one-of-a-kind to you as your taste in music. By means of our advanced assessment process, we will identify your specific needs and course of treatment. After a joint has been treated, there would not be a need to retreat the area unless trauma or new damage was experienced. A lot of our Regenerative Patients have experienced substantial relief after just one treatment.
4. What determines my results?
Degree of damage, location of treatment, and general health can all contribute to the outcome of your Regenerative Therapy. Most of our patients respond very well to this course of treatment and unlike surgical or pharmaceutical approaches, experience pain relief in a short time period.
5. How can I improve the effectiveness of my therapy?
We concentrate on you as a whole person, not just the area of your pain. Individuals that discontinued their pain medication and committed to being more active have experienced the best results. Our treatment team will develop a comprehensive program using the most advanced treatment modalities. Following the guidance of our Medical professionals will provide you with the most successful recovery possible.
6. How much downtime can I expect?
Again, you and your situation are unique but for the majority of our patients experience little to no downtime. We recommend our patients to be as active as possible after their therapy.
7. How long does the process take?
Starting immediately right after your treatment, regenerative cells will continue to work and repair on the injured areas.
8. Is it possible the therapy can fail?
Regenerative Cellular Therapy provides amazing results on a vast array of ailments and conditions. Our focus is on reducing discomfort, gaining mobility and range of movement, and greatly improving functional ability to move the body. The length of time to achieve this differs, as this is a regenerative process, not a quick fix. Symptom improvement varies patient to patient.
However, as is the case with any other medical procedure, there is no 100% guarantee. In specific cases, patients have had to undergo additional treatments.
9. If I don't get the results I want, can I still undergo surgery?
Certainly. There is nothing in our Regenerative Therapy treatments that would inhibit you from having surgery. Once we have completed our assessments and feel that surgery is the best option for you, we will advise you on that course. Our mission is always to do what will best serve our patients.