Frequently Asked Questions about Amniotic Fluid & Growth Factor Injury & Arthritis Clinical Research Study
How many visits will the treatment require?
You will need to attend clinic for two visits, 1 week apart.
Where will treatment take place?
Dr Stone, the Principal Investigator for this study is located at The Stone Clinic, 3727 Buchanan Street, Suite 300, San Francisco, CA 94123 http://www.stoneclinic.com/directions
Which products are used in The Stone Clinic?
The Stone Clinic uses amniotic fluid and PRP. The Stone Clinic primarily uses amniotic Fluid / Growth Factors but can also provide Platelet Rich Plasma (PRP) depending on personal choice and clinical need.
What is Platelet Rich Plasma (PRP)
Platelet Rich Plasma (PRP) is an outpatient procedure that involves a procedure to take a small amount of a patient's blood, isolates the platelets and injects the growth factors they release directly into the injured area, where they promote the body's natural healing response. The PRP has the benefit of stimulating the release of stem cells from vessel walls further augmenting repair. Stem cells are also being directly added to our cartilage regeneration efforts.
Where does the Stone Clinic source the amniotic Fluid / Growth Factors?
For the current clinical trial, The Stone Clinic primarily uses amniotic growth factors from Amnio Technology. https://amniotechnology.com/products/palingen-inovoflo/.
PalinGen® InovoFlo™ is a human tissue allograft comprised of amniotic fluid components, which include:
· Fibroblast Growth Factor (FGF)
· Epidermal Growth Factor (EGF)
· Platelet Derived Growth Factor (PDGF) A & B
· Vascular Endothelial Growth Factor (VEGF)
· Transforming Growth Factor beta (TGF-β)
· Hyaluronic Acid (HA)
· Interleukin-1 Receptor Antagonist (IL-1Ra)
· Tissue Inhibitor of Metalloproteinases 1 (TIMP-1)
· Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)
How is amniotic fluid retrieved and chosen for transplantation?
Amniotic fluid is collected from young, healthy mothers who donate the tissue at C-sections. All mothers (aged 18-45 years) are screened prior to consent and all components are tested to ensure safety and viability. Products are processed in accordance with current allograft tissue industry guidelines.
Are amniotic fluid / growth factor injections safe?
Donor fluid is recovered using one of the safest recovery techniques with sterile equipment to minimize any bioburden contamination. Amniotic fluid is procured through a network of qualified and trained recovery partners, following stringent screening and recovery protocols in a highly controlled processing environment. All fluids are processed aseptically.
Communicable disease testing is performed by an FDA registered and Clinical Laboratory Improvement Amendments (CLIA Certified) laboratory. Donor blood sample is taken prior to or at the time of recovery and tested for HBsAg, HBcAb, HCVAb, HIV1/2 Ab, HCV NAT, HIV NAT, HBV NAT, RPR/STS, WNV, and HTLV I/II. Allografts are subjected to stringent USP testing prior to release.
To date, there are no known negative side effects of the amniotic fluid / growth factors or the joint lubricants being used at The Stone Clinic.
Are there any studies that support the viability of stem cell/growth factor injections?
Amniotic fluid therapy has been studied in medical journals more than 7700 times. Most studies clearly show that it is superior to platelet rich plasma (PRP), bone marrow derived stem cell therapy, fat derived stem cell therapy, hyaluronic acid, and steroid injections.
Are amniotic fluid / growth factors approved by the FDA?
Amniotic fluid / growth factors are not under FDA regulation in California.
Are there any long term side effects?
There are been no reports of long term adverse reactions/outcomes.
What is the process for Amniotic Fluid / Growth Factor Injections?
The preference at The Stone Clinic is to use the combination of a joint lubricant injection (Hyaluronic Acid) with the amniotic fluid and growth factor injection whenever tissues are injured to accelerate the process of healing and, in the setting of arthritis, to diminish the symptoms of pain, swelling, and stiffness. This ‘3-in-1’ Injection consists of 7.5ml of Hyaluronic Acid and 1ml amniotic Fluid / Growth Factors. The injection is performed as an outpatient procedure and most patients are able to return to normal activity immediately. The Clinic recommends a session of physical therapy immediately after the injection to ensure optimal benefit.
How effective are Amniotic Fluid / Growth Factor injections?
The effectiveness of injections varies from patient to patient. Studies are currently underway within in our clinic to evaluate the effect of hyaluronic acid/amniotic fluid/growth factor injections on the composition of the synovial fluid (natural lubrication) in the knee.
When will the treatment outcome become noticeable?
Most patients experience a benefit within 4 weeks of the injection. Our Patient Reported Outcome Measure Study (PROMS) will help us to answer this question in more detail
How often will I need to repeat the injection?
We are currently researching the optimal treatment plan for our patients. However, most patients gain between 6 and 12 months of benefit from their amniotic fluid / growth factor injection. There is no limit to how many injections you can have.
Are amniotic fluid/growth factor injection procedures covered by my insurance?
Currently amniotic fluid/growth factor injections are not FDA-regulated; therefore, many insurance companies have yet to acknowledge them as a needed medical procedure. The cost of the procedure is the responsibility of the patient. We will however provide you with a ‘superbill' (a single bill compiling all charges and services)after treatment which you can submit to your insurance company. Some insurance companies will cover hyaluronic acid injections.
How much will an amniotic fluid/growth factor procedure cost?
For those who qualify to enroll in our current clinical trial, the cost will be $1000 to participants of our IRB-approved amniotic fluid / growth factor research study.
Do I need to participate in follow-up questionnaires?
Yes. You will need to fill out a 1, 3, 6, 12 & 18-month follow-up questionnaires through the online dashboard Lynxcare.
WANT TO BE CONSIDERED FOR THIS STUDY?
If you would like to be considered for participation in the study, please fill out the questionnaire below and our research team will follow up with you to verify if you qualify for this study.