Unlocking Regeneration with HCT/P Therapy

At Lumati, we believe that supporting cellular health is an important foundation of overall wellness. Our bodies naturally utilize stem cells as part of general repair and renewal processes, though research suggests this activity may change over time due to aging, stress, and environmental factors. Alongside healthy sleep, exercise, and nutrition, the field of regenerative medicine is exploring new approaches to supporting the body's natural processes.*

The information in this article is intended solely to inform and educate about ongoing developments in the field of regenerative medicine. It is not intended to make any claims about the availability, effectiveness, or appropriateness of any product for medical treatment. Always consult your healthcare provider before pursuing any new therapy.

What Are HCT/P Products?

HCT/P stands for Human Cell and Tissue Products. This refers to a category of regulated products consisting of human cells, tissues, or organs intended for transplantation, infusion, or transfer into a patient, in accordance with FDA regulations under Title 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

HCT/P therapy is an active and evolving area of scientific and medical research. At Lumati, we work exclusively with ethically sourced, FDA-compliant HCT/P products that meet applicable regulatory standards.*

The FDA has not cleared any stem cell-based or exosome products for general use, other than cord blood-derived hematopoietic progenitor cells for certain specific indications. These products have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease. Federal law restricts the use of these products for sale by or on the order of a physician.

What Are Stem Cells?

Stem cells are a subject of significant ongoing scientific research. They are naturally found in bone marrow, adipose tissue, and umbilical cord blood, and researchers are studying their potential role in the body's general repair and renewal processes.

Research has also explored exosomes — small extracellular vesicles that may play a role in cellular communication. This remains an active and evolving area of scientific inquiry.*

This information is provided for general educational purposes only and does not constitute a claim that any Lumati product or service delivers specific stem cell or exosome-related outcomes.

Lumati's Supportive Wellness Modalities

Lumati offers a range of general wellness modalities that may be used as part of a broader wellness routine. These are not intended to replace medical treatment and are offered as general wellness support only.*

• Red Light+ Therapy — A photobiomodulation modality being studied for its potential general cellular wellness and physical recovery support applications*

• Hydrogen Therapy — An emerging wellness modality being explored for its potential general antioxidant properties*

• Pulsed Electromagnetic Field (PEMF) Therapy — A modality being studied for its potential interactions with general circulation and cellular wellness*

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These modalities are intended for general wellness purposes only. They are not intended to diagnose, treat, cure, or prevent any disease. They are not established as preparatory or enhancement therapies for any HCT/P product. Individual results may vary. Consult your healthcare provider before use.

Regenerative Wellness Services at Lumati

Lumati offers several wellness services in the regenerative space, each administered under the supervision of a licensed provider and tailored to individual needs following a thorough assessment.*

• Regenerative Hair and Skin Services — Utilizing advanced techniques including microneedling in combination with biologic products, as part of a personalized wellness consultation*

• Regenerative Joint Support Services — Incorporating HCT/P cellular products as part of a provider-supervised wellness program*

• Microneedling Hair Restoration — A scalp wellness service designed to support general hair and scalp health*

• Sexual Wellness Services — Utilizing regenerative biologics as part of a personalized provider-supervised wellness consultation*

All services are administered by or on the order of a licensed physician. Any provider administering an HCT/P therapy shall have sole discretion and responsibility to determine, in accordance with applicable law and professional standards, whether the product is suitable for any intended use. These services are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary.

Navigating the Regulatory Landscape

The field of HCT/P therapy is growing rapidly, and regulatory compliance is essential. At Lumati, we are committed to working only with products that comply with applicable FDA regulations. We encourage all prospective patients to consult with their provider, review current scientific literature, and refer to FDA and state medical authority resources for the most up-to-date information about HCT/P products and ongoing clinical research.

Important Regulatory Disclosures

• The FDA has not cleared any stem cell-based or exosome products for general use, other than cord blood-derived hematopoietic progenitor cells for certain specific indications.

• These products have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease.

• Products referenced comply with FDA regulations under Title 21 CFR Part 1271 and Section 361 of the Public Health Service Act as HCT/P products.

• Any provider administering an HCT/P therapy shall have sole discretion and responsibility to determine in accordance with applicable law and professional standards whether the product is suitable for any intended use.

• Federal law restricts the use of these products for sale by or on the order of a physician.

• No individuals were compensated or provided free products in exchange for any testimonial.

• This document is intended solely to inform and educate medical professionals and their patients about developments in regenerative medicine. It is not intended to make any claims about the availability, effectiveness, or appropriateness of these products for medical treatment.

  
  

Always consult your provider, review current scientific literature, and refer to the FDA and your state medical authorities for current information about HCT/Ps and to evaluate findings from clinical trials.

Interested in learning how Lumati's BioRegen Program may support your wellness journey? Reach out to us at info@lumati.com.

This information is not intended as medical advice. All services are provided under the supervision of a licensed physician. Individual results may vary.

Want to dive deeper? Read the full report on Regeneration Through HCT/P Therapy here.  

If you’re interested in learning how Lumati’s BioRegen Program can support your health journey, reach out to us at info@lumati.com.  

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This document, and the information contained, is intended solely to inform and educate medical professionals and their patients about ongoing developments and innovations in the field of “Regenerative Medicine”. Readers should not rely on any information in this document solely to make medical decisions. This information is not intended to make any claims or representations about the availability, effectiveness, or appropriateness of these products in medical treatment.

Products depicted in the document have been determined to comply with the U.S. Food and Drug Administration's (FDA) regulations contained in Title 21 Part 1271 of the Code of Federal Regulations, Section 361 of the Public Health Service Act, as a Human Cell and Tissue Product (HCT/P). 

Any provider administering an HCT/P therapy shall have sole discretion and responsibility to determine in accordance with applicable law and professional standards if the product is usable and suitable for any and all intended uses and situations. Any user of the products accepts and shall have full responsibility and liability with respect to such use. 

Consult with your provider, scientific literature, and governmental agency databases and websites, including those of the Food and Drug Administration (FDA), and your state Medical Authorities for more information about HCT/Ps and to evaluate current information from clinical trials. 

Note: The FDA has not cleared any stem cell-based or exosome products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications. These products have not been evaluated by the Food and Drug Administration, and are not intended to diagnose, treat, cure, or prevent any disease. Individuals were not paid or given free products in exchange for their testimony. 

Caution: Federal law restricts the use of the product for sale by or on the order of a physician.

w restricts the use of the product for sale by or on the order of a physician.