FDA


 

Are these treatments FDA approved?

Regenerative cell therapy isn’t FDA approved. However, the U.S. Department of Health and Human Services has called regenerative medicine “the next evolution of medical treatments.” They further note: “This revolutionary technology has the potential to develop therapies for previously untreatable diseases and conditions.”

The regenerative cell therapy conducted at GIOSTAR Chicago is done in accordance with FDA regulations. Regenerative cell therapy and bone marrow transplants have been used for more than 25 years in the United States to treat a number of medical conditions, including sickle cell anemia, leukemia, thalassemia, and lymphoma.

The researchers and scientists at GIOSTAR Chicago adhere to the scientific and ethical guidelines set up by the National Institute of Health (NIH), International Society for Stem Cell Research (ISSCR), and International Society for Cell & Gene Therapy (ISCT).

The specialists at GIOSTAR Chicago also closely follow the guidelines for regenerative cell therapy set by the World Medical Association (WMA) Declaration of Helsinki that establishes ethical standards for medical research involving human subjects. It states: “In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgment it offers hope of saving life, re-establishing health or alleviating suffering.”

All regenerative cell therapy research is done at respected universities throughout the United States, and the peer-reviewed published research papers are readily available to all onPubMed, which is a complete database of biomedical literature, scientific journals, and online books maintained by the NIH.

Opinions and statements offered on this website are for informational and educational purposes only, and not meant to serve as medical advice. At GIOSTAR Chicago, the specialists offer certain investigational treatments using adipose or bone marrow from your own cells, which is known as an autologous transplant. Surgical procedures aren’t conducted, nor are experimental medications used.

GIOSTAR Chicago doesn’t claim that the application of regenerative cell therapy can cure, treat, or prevent any medical condition or hematological disorder. The specialists at GIOSTAR recommend you conduct your own research on regenerative cell therapy to help you reach your own informed decision as to whether you may benefit from treatment. Participation in regenerative cell therapy at GIOSTAR Chicago is a voluntary decision, including for those who participate in clinical studies.

The testimonials, statements, and opinions presented on this website are only applicable to the individuals themselves. Your exact results may vary from what others have experienced, including the patient testimonials found on this website. The primary goal at GIOSTAR Chicago is to create a positive change for the human race, from research to treatment.

To learn more about regenerative cell therapy, call GIOSTAR Chicago or use online booking to schedule a consultation.

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