Regenerative Medicine
Enlightenment towards New Medicine
Special Invitation - AAPI Members
EXPLORING THE PROCESS
WHAT YOU NEED TO KNOW
1. It is important to work with a lab that follows FDA guidelines for safety and quality in manufacturing. Stem cell therapy is still considered experimental but has shown great success as reported by patients. There are thousands of clinical trials going on right now.
2. No different than many other medical options, Stem Cell Therapy results are not guaranteed. Patients are required to sign a release form.
3. The Stem Cell Products we use are the most immature cells available and are not pre-programmed to become a certain type of tissue. Different Stem Cells serve different purposes, the body determines where they go and how they are used. They are a “blank slate” till the body tells them what to do. The body is in charge of the repair and regeneration process.
4. Stem Cells don’t treat any disease or condition, they are a resource your body used to have, but as we age that resource shrinks/depletes, so we are reintroducing that resource back to the body so that the body can use them to cushion, support, and protect. We are giving the body resources to allow it to repair and regenerate.
5. We use cells from healthy babies and healthy mothers that are donated and go through all the screening processes and procedures required by the FDA. The cells are non-tumorigenic and undifferentiated making them one of the safest forms of Stem Cell Therapy. We fully support this process, and that is why we work closely with reputable labs that work hand in hand with the FDA.
6. There are many thousands of successful therapies and patients are eager to share their stories.
2. No different than many other medical options, Stem Cell Therapy results are not guaranteed. Patients are required to sign a release form.
3. The Stem Cell Products we use are the most immature cells available and are not pre-programmed to become a certain type of tissue. Different Stem Cells serve different purposes, the body determines where they go and how they are used. They are a “blank slate” till the body tells them what to do. The body is in charge of the repair and regeneration process.
4. Stem Cells don’t treat any disease or condition, they are a resource your body used to have, but as we age that resource shrinks/depletes, so we are reintroducing that resource back to the body so that the body can use them to cushion, support, and protect. We are giving the body resources to allow it to repair and regenerate.
5. We use cells from healthy babies and healthy mothers that are donated and go through all the screening processes and procedures required by the FDA. The cells are non-tumorigenic and undifferentiated making them one of the safest forms of Stem Cell Therapy. We fully support this process, and that is why we work closely with reputable labs that work hand in hand with the FDA.
6. There are many thousands of successful therapies and patients are eager to share their stories.
KNOW YOUR LAB
- What is the corporate structure and are the financials transparent?
- Does leadership have an extensive healthcare background?
- Is the company and/or leadership reputable? A web search of financial / business fraud?
- Is the company vertically integrated?
- Do they manage and control tissue procurement?
- Does the company own the laboratory or leverage a contracted lab?
- Is the ownership or relationship with the lab transparent?
- Has the lab been audited by the FDA and posted on the FDA database?
- Is the laboratory accredited / compliant? ISO, AATB, AAB, CGTP, CGLP
- What are the serology and sterility standards?
- Has the company had any major adverse events or product recalls?
- Will the organization offer regulatory, medical board and malpractice support?
- Does the company offer marketing support staff and materials?
- Do website and marketing material follow FDA objective intent marketing guidelines?
- Does leadership have an extensive healthcare background?
- Is the company and/or leadership reputable? A web search of financial / business fraud?
- Is the company vertically integrated?
- Do they manage and control tissue procurement?
- Does the company own the laboratory or leverage a contracted lab?
- Is the ownership or relationship with the lab transparent?
- Has the lab been audited by the FDA and posted on the FDA database?
- Is the laboratory accredited / compliant? ISO, AATB, AAB, CGTP, CGLP
- What are the serology and sterility standards?
- Has the company had any major adverse events or product recalls?
- Will the organization offer regulatory, medical board and malpractice support?
- Does the company offer marketing support staff and materials?
- Do website and marketing material follow FDA objective intent marketing guidelines?
- Is the company and/or leadership reputable? A web search of financial / business fraud?
- Is the company vertically integrated?
- Do they manage and control tissue procurement?
- Does the company own the laboratory or leverage a contracted lab?
- Is the ownership or relationship with the lab transparent?
- Has the lab been audited by the FDA and posted on the FDA database?
- Is the laboratory accredited / compliant? ISO, AATB, AAB, CGTP, CGLP
- What are the serology and sterility standards?
- Has the company had any major adverse events or product recalls?
- Will the organization offer regulatory, medical board and malpractice support?
- Does the company offer marketing support staff and materials?
- Do website and marketing material follow FDA objective intent marketing guidelines?