FDA and Stem Cell Therapy

Are These Treatments FDA Approved?

At the current time, regenerative cell therapy isn’t approved by the United States Food and Drug Administration (FDA). However, the U.S. Department of Health and Human Services has called regenerative medicine “the next evolution of medical treatments.” They further note that “this revolutionary technology has the potential to develop therapies for previously untreatable diseases and conditions.”

The regenerative cell therapy conducted at GIOSTAR Chicago is performed 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 established 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. This declaration states that:

“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.”

Research in regenerative cell therapy is performed at well-respected universities throughout the United States. Peer-reviewed published research papers are readily available to all on PubMed, 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 that all patients educate themselves 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, please contact us today by completing our brief Contact Us form, calling us (844 446 7827), or emailing us (


Get an Appointment

Complete The Form Below And We’ll Get Back To You Immediately.


Hear What Our Patients Are Saying.

Read More