Frequently Asked Questions about Stem Cell & 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

What will I need to provide to be considered for this study?

First, you must complete our eligibility questionnaire. If you are eligible to  participate in this research study, you will be required to have a consultation at The Stone Clinic. If you live outside the Bay Area, The Stone Clinic can arrange a complimentary phone consultation with Dr Stone. They will talk to you about the history of your injury or pain and ensure they have all the right diagnostic images to make an accurate evaluation. You can take MRI and digital diagnostic x-ray images at The Clinic. Alternatively, you may get these images done elsewhere or bring in recent images (taken within the past year) that you already have.

What are stem cells?

Stem cells are both growth factor engines and directors of the complex cycle of tissue regeneration at the sites of injury. Stem cells have natural anti-inflammatory, anti-scarring, and anti-microbial properties. They also stimulate other cells to produce additional growth and lubricating factors.

Where do stem cells come from?

Stem cells and growth factors are available from fat tissue, bone marrow, and the amniotic fluid from healthy C-section deliveries.

Which stem cell products are used in The Stone Clinic?

The Stone Clinic can uses PRP, BMAC and amniotic stem cells. The Stone Clinic primarily uses amniotic stem cells but can also provide Platelet Rich Plasma (PRP) and Bone Marrow Aspirate Concentrate (BMAC) 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.

What is Bone Marrow Aspirate Concentrate (BMAC)

Bone marrow aspirate concentrate (BMAC) is a biologic concentrate that is derived from a patient’s own bone marrow. The patient undergoes a procedure in the operating room to extract the bone marrow which is then processed before being injected back into the patient. Concentrated BMA is high in mesenchymal stem cells (MSCs) and hematopoietic stem cells (HSCs), which are known to be critical in biological processes such as tissue regeneration and bone formation.

Where does the Stone Clinic source the amniotic stem cells?

The Stone Clinic primarily uses amniotic stem cells 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 are Amniotic stem cells 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 stem cells 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 stem cells, growth factors or the joint lubricants being used at The Stone Clinic.

Are live cells present in the amniotic stem cell injections?

The amniotic stem cell preparation The Stone Clinic uses combines 97% viable cells and 1-3% stem cells. The fluid has 2 - 50 times the concentration of the 1,100 growth factors found in the blood. It is the most potent combination of stimulants to assist in healing known with no rejection potential and no potential of these cells to transform into any unwelcomed cell.

Are there any studies that support the viability of stem cell/growth factor injections?

Amniotic fluid stem cell 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 stem cells approved by the FDA?

Amniotic stem cells 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 Stem Cell Injections?

The preference at The Stone Clinic is to use the combination of a joint lubricant injection (Hyaluronic Acid) with the amniotic stem cells 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 stem cells. 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 stem cell/growth factor injections?

The effectiveness of stem cell/growth factor injections varies from patient to patient. Studies are currently underway within in our clinic to evaluate the effect of hyaluronic acid/stem cell/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 stem cell injection. There is no limit to how many injections you can have.

Are amniotic stem cell/growth factor injection procedures covered by my insurance?

Currently amniotic stem cell/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 and BMAC injections.

How much will an amniotic stem cell/growth factor procedure cost?

The cost of a stem cell injection will be approximately $4,000 in addition to an office visit and the associated costs. Financial considerations may be offered to participants of our IRB-approved stem cell research studies.


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.