Stemcell Research

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Tissue/Cells ability to differentiate and secrete trophic factors has important potential for tissue regeneration and repair.

Stem cell paracrine actions and tissue regeneration.
Baranaki PR & McDevitt TC. Regenerative Medicine. 2010 Jan. 

Abstract Link:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2833273/ 

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Tissue treatment was found to produce significant improvement in a large study of patients with rheumatoid arthritis according to validated questionnaires.

Human umbilical cord mesenchymal stem cell therapy for patients with active rheumatoid arthritis: safety and efficacy.
Wang et al. Stem Cells Development. 2013 Dec.

Abstract Link:  https://pubmed.ncbi.nlm.nih.gov/23941289/

Local injection of mesenchymal stem cells has been shown to improve joint function due to stem cells’ ability to repair and regenerate cartilage tissue.

Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial.
Jo CH et al. Stem Cells. 2014 May. Abstract

Safety and Complications Reporting on the Re-implantation of Culture-Expanded Mesenchymal Stem Cells using Autologous Platelet Lysate Technique.

Centento CJ. Current Stem Cell Research & Therapy. 2010. Abstract

Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial.
Saw KY et al. Arthroscopy. 2013 Apr. Abstract

Increased knee cartilage volume in degenerative joint disease using percutaneously implanted, autologous mesenchymal stem cells.
Centeno CJ et al. Pain Physician. 2008 May. Abstract

Partial regeneration of the human hip via autologous bone marrow nucleated cell transfer: A case study.
Centeno CJ et al. Pain Physician. 2006 Jul. Abstract

IMMUNOMODULATION

Immunomodulation is a key property of regenerative therapy cells that allows them not to elicit a patient immune response. Studies show that umbilical cord cells are safe and comparable to bone marrow derived cells, with great potential for therapeutic use.

Efficient expansion of mesenchymal stromal cells from umbilical cord under low serum conditions.
Girdlestone J et al. Cytotherapy. 2019. Abstract

In vitro immunologic properties of human umbilical cord perivascular cells.
Ennis J et al. Cytotherapy. 2008. Abstract

Immunological properties of extraembryonic human mesenchymal stromal cells derived from gestational tissue.
Stubbendorff M et al. Stem Cells Development. 2013 Oct. Abstract

CD14+ monocytes promote the immunosuppressive effect of human umbilical cord matrix stem cells.
Wang D et al. Experimental Cell Research. 2010 Sep. Abstract

The tissue regenerative properties of stem cells make them a unique tool for repairing cartilage after injury, serving as an alternative to surgery. Stem cells’ action on cartilage can reduce pain and improve joint function for patients who have suffered joint injuries.

In the human body, stem cells participate in bone healing after a fracture. Harnessing their osteogenic properties, stem cell treatment can aid in bone union to improve fracture recovery.

Arthritis is a condition of the joints that can become debilitating due to pain and decreased range of motion. While manifestations of arthritis differ from patient to patient, the underlying cause is chronic systemic inflammation. Mesenchymal stem cells are anti-inflammatory, allowing them to reduce the impact of arthritis. Studies that used stem cells to treat knee osteoarthritis have found the treatment to help patients to walk longer and climb more stairs, and have observed long-term improvement at 5-year follow-up, compared to baseline.

References for Arthritis Data:

http://www.cdc.gov/arthritis/data_statistics/arthritis-related-stats.htm

http://www.arthritis.org/about-arthritis/understanding-arthritis/what-is-arthritis.php

http://circres.ahajournals.org/content/100/9/1249

Stem cell therapies have great potential in treating a range of chronic conditions. This site serves to inform people about stem cell regenerative medicine, stem cell products, and products that help support healthy cells.
While umbilical cord stem cell products are produced in an FDA compliant laboratory, they have not been approved by the FDA for treatment effectiveness. Stem cell products are governed by FDA CFR Title 21 1271 Rule 361 for HUCT’s. 

The FDA states: Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.

If you are interested in stem cell therapy, consult with our healthcare providers. 

Licensed medical professionals are available for consultations to discuss your specific needs so you can decide if regenerative medicine and stem cell therapy are right for you, as well as integrative nutrition methods.  Your health is an extremely personal decision. The best investment you can make is in your health. As with structured diets, health coaches, trainers, gyms, yoga, and holistic medicine there are costs not currently covered by insurance. 

NEUROPATHIC PAIN

https://pubmed.ncbi.nlm.nih.gov/23572051/  (Read more by clicking on the study link)

Abstract:

Neuropathic pain is a chronic condition that is heterogeneous in nature and has different causes. Different from and more burdensome than nociceptive pain, neuropathic pain more severely affects people's quality of life. Understanding the various mechanisms of the onset and progression of neuropathic pain is important in the development of an effective treatment. Research is being done to replace current pharmacological treatments with cellular therapies that will have longer lasting effects. Stem cells present an exciting potential therapy for neuropathic pain. In this review, we describe the neuroprotective effects of stem cells along with special emphasis on the current translational research using stem cells to treat neuropathic pain. 

IS THIS FDA APPROVED?

Regenlife Tissue Therapy offers state-of-the-art stem cell procedures and utilizes “361” FDA compliant unmanipulated, homologous biomolecules and rich tissue grafts, 361 products that meet all the criteria outlined in 21 CFR 1271.10(a) are regulated as HCT/Ps and are not required to be licensed or approved by the FDA. These products are called “361 products,” because they are regulated under Section 361 of the Public Health Service (PHS) Act.

Human cells, tissues, and cellular and tissue-based products (HCT/Ps) consist of human cells or tissues intended for implantation, transplantation, infusion or transfer into a human recipient.

 These ingredients have the potential to boost your body's ability to heal damaged cells and tissues and could help you recover more quickly.

https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/hctps

OverviewHuman cells, tissues, and cellular and tissue-based products (HCT/Ps) consist of human cells or tissues intended for implantation, transplantation, infusion or transfer into a human recipient. The Food and Drug Administration regulates a cellular therapy product solely as an HCT/P (i.e. "361 product") if it meets all the following criteria in 21 CFR 1271.10(a):The product is minimally manipulated.The product is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent.The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article — except for water, crystalloids or a sterilizing, preserving or storage agent — provided that the addition of water, crystalloids or the sterilizing, preserving or storage agent does not raise new clinical safety concerns with respect to the HCT/PAnd either: Does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function, orHas a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and is forAutologous useAllogeneic use in a first or second-degree relative orReproductive use.HCT/Ps are subject to the regulations in 21 CFR 1271 including establishment registration, donor eligibility (donor screening and testing), Current Good Tissue Practice (CGTP), additional regulatory requirements (adverse reaction reporting, HCT/P deviation reporting and labeling), and exemptions and alternative procedures. The regulatory requirements for allogeneic products are more extensive than for autologous products but, in general, FDA regulations emphasize preventing the risk of communicable disease transmission by HCT/Ps. Premarket review (licensure, clearance, and approval) by the FDA is not required for HCT/Ps.Examples of HCT/Ps are listed below:BoneHeart valve, Manipulated autologous chondrocytes, Ligament, Cornea, Hematopoietic progenitor(stem) cells (HPC) from peripheral and cord blood, Skin, Semen, Decellularized particulate human placental connective tissue matrix, Epithelial cells on a synthetic matrix, Other reproductive tissue, Dura mater, 

AABB's Standards for Blood Banks and Transfusion Services defines accreditation requirements for facilities involved in collecting, processing, distributing, and transfusing blood and blood components. Because blood centers and transfusion services may store and dispense tissues (i.e., bone, ligament, and skin), these products are addressed in the general quality system requirements of the AABB Standards. 

Although the FDA requires tissue banks to track tissues from the donor to the consignee (or final disposition), hospitals are considered exempt from this requirement.

 AABB and other standards and accreditation programs have been working to implement ISBT-128 labeling — a standardized system widely used in the blood banking, tissue and cellular therapies industries — to preserve the traceability of tissue products. Activities related to the preparation and dispensing of tissues and associated record-keeping requirements are addressed in AABB's Standards.

HPCs can be obtained from different sources (marrow, cord blood, peripheral blood) and are used in a variety of therapeutic applications. HPC from marrow is regulated by the Health Resources and Services Administration, and HPC from peripheral blood collected by apheresis is regulated as an HCT/P.

https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Regulation-of-Human-Cells--Tissues--and-Cellular-and-Tissue-Based-Products-%28HCT-Ps%29---Small-Entity-Compliance-Guide--Guidance-for-Industry.pdf

https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/fda-regulation-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-product-list

Currently, the FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for regulating HCT/Ps and it has two different paths for cell therapies that it constructed to reflect what it considers to be “relative risk”. These pathways are commonly called “361” and “351” products.

Cell therapies can potentially be regulated under either pathway, as described below:

361 Products

361 products that meet all the criteria outlined in 21 CFR 1271.10(a) are regulated as HCT/Ps and are not required to be licensed or approved by the FDA. These products are called “361 products,” because they are regulated under Section 361 of the Public Health Service (PHS) Act.

351 Products

In contrast, if a cell therapy product does not meet all the criteria outlined in 21 CFR 1271.10(a)), then it is regulated as a “drug, device, or biological product” under the Federal Food, Drug, and Cosmetic Act (FDCA) and Section 351 of the PHS Act. These 351 products require clinical trials to demonstrate safety and efficacy in a process that is nearly identical to that what is required for pharmaceutical products to enter the marketplace.