Regenerative Sciences and the FDA - FAQs


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Regenerative Sciences and the FDA - FAQs

What is the medical procedure that the FDA claims is an ?adulterated? and ?misbranded? drug?
The Regenexx? procedure involves taking the patient's own stem cells via a needle from the bone marrow, growing them in culture to bigger numbers, and then re-injecting them into the area in need of repair. It is only used for orthopedic problems like arthritis, tendon or ligament tears, or bulging lower back discs.

Why does the FDA consider these cells adulterated? What are cGMP?
cGMP (Current Good Manufacturing Practices) are federal drug mass manufacturing standards that would be used by a factory producing millions of doses of drugs as opposed to medical practices treating one patient at a time. The FDA is claiming that since these guidelines are not followed, the stem cells processed by Regenerative Sciences are "adulterated".

Do medical clinics use cGMP drug mass manufacture guidelines?
No. Hospitals and medical clinics processing the patient's own tissue use a different standard called cGTP (good tissue practices). Surgical procedures don't use either standard, nor do medical clinics. cGMP guidelines were designed to ensure safety when millions of drug doses are being produced and sent across the nation, not for medical clinics to administer to individual patients. Medical practices processing stem cells can also use ICMS guidelines (International Cellular Medicine Society).

Why is the FDA's press release focused on cGMP guidelines not being followed? Regenerative Sciences already strictly adheres to the International Cellular Medicine Society?s (ICMS) professional guidelines and has a third party, independent vendor check it's compliance. The FDA knew in spring of 2009 that Regenerative Sciences had no intention of adhering to cGMP drug guidelines as Regenerative Sciences does not produce drugs. The FDA declared there were no serious safety concerns by taking no action in 2009. For example, Regenerative Sciences received no warning letter nor cease and desist letter. Regenerative Sciences believes the agency's focus on this issue now is a litigation tactic.

How much would medical care cost if cGMP guidelines were applied to a hospital operating room or emergency room?
Medical costs would undoubtedly sky rocket. We estimate that a knee surgery that is paid by insurance now at $1,200 would easily cost 10-100 times as much if the operating room used drug factory production guidelines. In the meantime, no measureable additional safety would be added. Medical care would grind to a halt.

Was Regenerative Sciences engaged in selling any cell products in "interstate commerce", which requires FDA jurisdiction?
No. Regenerative Sciences is a medical practice that only used its own patients cells by injecting the same patient at its facilities in Colorado.

Please respond to the comment published in the FDA release: "?When companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public's health at risk."
Regenerative Sciences is not a threat to the public. It has a flawless medical compliance record. Regenerative Sciences has also published a large safety study indexed in the National Library of Medicine that shows that their Regenexx? procedure is dramatically safer than the more invasive surgical procedures it helps to replace. Any allegation that Regenerative Sciences is an imminent threat to the public is belied by the fact that Regenerative Science's facilities were inspected in 2009 and were found by the FDA not to be cGMP compliant. FDA took no action at that time. In fact, in the approximately five years that Regenerative Sciences has been operational, there have been no serious stem cell related complications in over 397 patients and 941 stem cell procedures. This is documented by the ICMS, a nonprofit patient safety and education organization, as well as the clinic itself. There have also been no reports or evidence of communicable disease transfer or of infectious disease introduction to patients.

How does the safety of this procedure compare to other common medical procedures?
The Regenerative Sciences cultured stem cell procedure (Regenexx?) has allowed many patients to avoid the need for joint replacement surgery. As an example, in a recent study by Regenerative Sciences, only 4% of patients who either needed a knee replacement or were told they would soon need one, opted for the knee replacement despite receiving the Regenexx? procedure. Knee replacement procedures are invasive. For every 200 such surgeries performed in the U.S., one patient death will occur and 10-20 serious complications will result. Regenerative Science's innovative injection procedure has produced no such safety concerns.

If Renerative Sciences was not following cGMP, what lab guidelines does it use to ensure patient safety?
Regenerative follows professional guidelines outlined by the ICMS for its lab. Independent audits are performed by Reglera. Regenerative Sciences is in full compliance with all ICMS guidelines, which are thorough and comprehensive, focusing primarily on patient safety, and has had its Reglera audits reviewed by the ICMS lab committee independent of any input from Regenerative Sciences.

What is the current action being taken by the FDA?
The FDA is seeking to enjoin Regenerative Sciences from practicing medicine using patient's own stem cells.

Why has the FDA taken this action?
The FDA has twice declared that the clinic?s therapeutic use of a patient's own stem cells, which are used to treat common orthopedic conditions, represent the manufacture of a new drug, which must come under federal control. Regenerative Sciences previously filed a suit in Denver District Court after a similar prior claim by the FDA, based on the fact that the regulation of medical facilities lies with the state and, as the FDA is a federal agency, they have no jurisdiction in the matter. In addition, Regenerative Sciences claims that the FDA's regulation making the patient's own stem cells a biologic drug is ultra vires, or beyond the power that congress granted the agency.

What is the history of this case?
Regenerative Sciences has been using its patient's stem cells to treat orthopedic conditions since 2005. The practice received an untitled letter from the FDA in 2008 claiming its medical procedure was creating a new biologic drug. Regenerative Sciences filed suit against FDA in 2008 and then again this year, to prompt the agency to declare how the FDA had the authority to regulate a medical practice, which Congress and the courts have always exempted from federal regulation. As recently as last month, Regenerative Sciences was forced to file suit against FDA seeking a Temporary Restraining Order (TRO) to prompt the FDA to take "final agency action" or leave it's medical practice alone. Regenerative Sciences has learned that the FDA has finally decided to take action by seeking to enjoin Regenerative Sciences from practicing medicine using its patient's own stem cells. This will finally push the dispute between Regenerative Sciences and the FDA into the courts for resolution.

Will Regenerative continue offering procedures using the patient's own stem cells? What the FDA believes is a drug is the culturing of cells used by Regenerative Sciences to produce greater numbers of cells for patient therapy. Regenerative Sciences counters that this is almost identical to other common medical procedures not under the FDA's control (like in-vitro fertilization). Regenerative Sciences has voluntarily decided to stop culturing cells until the legal case is decided, but it will still offer its patients same-day stem cell isolation procedures that are exempt from FDA regulations.

What is the projected timeline of events now that the FDA has taken action?
Regenerative Sciences will file its responses. The case may take a year or more to be decided in the judicial system.

What?s the ?big picture? around the use of adult stem cells? What will this case mean for the medical community?
The fundamental question here is ?Are adult stem cells body parts to be used by the doctor in any safe way that helps the patient? Or, are they drugs to be controlled by the FDA, patented, and sold in vials by pharmaceutical companies?? If they are body parts, the costs of therapies using these cells will be dramatically less. If they are deemed drugs, the costs of these therapies will be dramatically more. If they are body parts, doctors, using proper protocols, can begin using these cells to help patients almost immediately. If they are drugs, then there will be delays in the use of these cells for many conditions by 10 to 20 years or more.

Are there other countries around the world where the medical use of adult stem cells is approved by the government?
Many countries view the use of the patient's own stem cells differently than the US. Many would require a "registry" process, similar to how doctors now use bone marrow transplants or fertilized embryos, but would not consider them a new drug. The US has the most restrictive environment for the use of the patient?s own stem cells.

What do Regenerative Science's patients say about the actions the FDA has taken?
Barbara James - Boulder, Colorado?I am extremely disappointed in the FDA?s closed-minded thinking and disregard for patients who need pain relief.?

Harold Kaye - Denver, Colorado"I am downright angry at this decision. The Regenexx? procedure has changed my life. Before I met Drs. Centeno and Schultz, my life was plagued by physical pain. I was debilitated. I now have the strength and ability to live my retirement years as I have always wanted. It is sad that others in my situation may not get the chance to get this treatment here in the US, but it doesn?t surprise me that the Federal Government could be so short-sighted.?

If you have additional questions, please contact Jennifer Kardian at 678-352-3652 or