Safety, Science, and Regulatory Integrity
At Core Stem Cell Therapy, your safety and long-term recovery are our absolute priorities. We strictly adhere to FDA 21 CFR Part 1271 regulations, ensuring that every regenerative treatment we provide meets the highest federal standards for purity, safety, and compliance.
Drawing on over 34 years of advanced radiology experience at leading university teaching hospitals, Deborah Lingenfelter oversees our safety protocols with the same diagnostic precision used in trauma and complex imaging. By exclusively utilizing human cellular and tissue-based products (HCT/Ps) regulated under Section 361 of the PHS Act, we provide ethically sourced, minimally manipulated biologics designed to trigger your body’s natural healing potential without the risks of invasive surgery.
Understanding Section 361 Compliance
At Core Stem Cell Therapy, we ensure our biologics qualify as Section 361 products by meeting the four strict criteria defined in 21 CFR 1271.10(a):
- Minimal Manipulation: The HCT/P is minimally manipulated, meaning the processing does not alter the original relevant biological characteristics.
- Homologous Use Only: The HCT/P performs the same basic function in the recipient as in the donor.
- No Combination: The tissues are not combined with any article that raises new clinical safety concerns.
- No Systemic Effect: The primary function of the HCT/P is localized and non-dependent on metabolic activity.
The Gold Standard of Tissue Sourcing
At Core Stem Cell Therapy, we do not settle for “minimum requirements.” We exclusively partner with FDA-registered laboratories that exceed industry standards for safety and potency.
- Ethical Sourcing: All tissues are recovered from healthy, consenting donors during scheduled Cesarean sections. No harm is ever done to a mother or baby; these tissues are preserved for their immense regenerative signaling power.
- Independent CLIA-Certified Testing: Every donor and every batch of tissue undergoes rigorous testing for a comprehensive panel of communicable diseases.
- Third-Party Sterility Verification: Our products are verified by independent laboratories using U.S.P. 71 sterility testing to ensure zero contamination.
A Message from Our Founder
Throughout my 34 years in diagnostic radiology at leading university teaching hospitals, I have been held to the highest standards of trauma and complex imaging protocols. I have brought that same “zero-error” mindset to Core Stem Cell Therapy.
Compliance isn’t just about following the law—it’s about protecting you. By adhering strictly to Section 361 and CFR Part 1271, and by working under the mentorship of Dr. Mark Fedorczyk, I ensure that every patient who walks through our doors receives the safest, most effective regenerative care available today.
Frequently Asked Questions
Is the treatment FDA-Approved?
The FDA does not “approve” tissue-based procedures in the same way they approve drugs. However, the FDA regulates these products under Section 361 of the PHS Act. Our clinic operates strictly within these regulatory boundaries.
Are there side effects?
Because we use minimally manipulated human tissue for homologous use, the risk of “rejection” is extremely low. The most common side effect is localized soreness at the site of the injection.
Why isn’t this covered by insurance?
Most insurance providers currently view regenerative medicine as elective, despite growing clinical evidence. We focus on providing a superior, non-surgical alternative that often reduces long-term out-of-pocket expenses compared to surgery.
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