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RESEARCH STUDIES

Review pivotal studies on Regenerative Therapies

As further applications of regenerative therapies are studied, due to advancements in biomedical science, the rapidly growing area of research in regenerative therapies may potentially provide benefits for a variety of diseases and health conditions. Below you will find just some of the thousands of pivotal studies on the effectiveness of regenerative therapies in orthopedics, immunomodulation, autoimmune diseases, diabetes, and many other indications that have been published in key medical journals, publications, and public studies, and that number is continuing to grow every day.

Tissue Repair

Regenerative cells' ability to differentiate and secrete trophic factors has important potential for tissue regeneration and repair.

Cell paracrine actions and tissue regeneration. Baranaki PR & McDevitt TC. Regenerative Medicine. 2010 Jan. Abstract

Arthritis

Regenerative medicine was found to produce improvement in a large study of patients with rheumatoid arthritis according to validated questionnaires.

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

Osteoarthritis

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

Intra-articular injection of mesenchymal 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 Cells using Autologous Platelet Lysate Technique. Centento CJ. Current Stem Cell Research & Therapy. 2010. Abstract

Articular cartilage regeneration with autologous peripheral blood 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 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 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 cells. Wang D et al. Experimental Cell Research. 2010 Sep. Abstract

Heart Disease

Differentiation abilities allow cells to replace heart muscle cells that have been damaged by cardiovascular disease, improving heart muscle ability.

Comparison of allogeneic vs autologous bone marrow-derived mesenchymal cells delivered by transenodcardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. Hare JM et al. JAMA. 2012 Dec. Abstract

Mending a broken heart: cells and cardiac repair. Goldthwaite CA. NIH.gov Article

Diabetes

Documented use of cells for diabetes patients includes boosting insulin-producing cells and reversing certain complications.

Generation of insulin-producing cells from human bone marrow mesenchymal stem cells by genetic manipulation. Karnieli O et al. Stem Cells. 2007 Nov. Abstract

Mesenchymal cells protect NOD mice from diabetes by inducing regulatory T cells. Madec AM et al. Diabetologia. 2009 Jul. Abstract

Immunomodulatory function of bone marrow-derived mesenchymal cells in experimental autoimmune type 1 diabetes. Fiorina P et al. Journal of Immunology. 2009 Jul. Full Text

Mesenchymal cells prevent the rejection of fully allogenic islet grafts by the immunosuppressive activity of matrix metalloproteinase-2 and -9. Ding Y et al. Diabetes. 2009 Aug. Full Text

Mesenchymal cells enhance allogeneic islet engraftment in nonhuman primates. Berman DM et al. Diabetes. 2010 Oct. Full Text

Lupus

Several studies have shown that cells benefit patients with the autoimmune disease lupus.

Umbilical cord mesenchymal cell transplantation in active and refractory systemic lupus erythematosus: a multicenter clinical study. Wang D et al. Arthritis Research & Therapy. 2014 Mar. Abstract

Allogeneic mesenchymal cell transplantation in severe and refractory systemic lupus erythematosus: 4 years of experience. Wang D et al. Cell Transplantation. 2013. Abstract

Autologous mesenchymal cell treatment increased T regulatory cells with no effect on disease activity in two systemic lupus erythematosus patients. Carrion F et al. Lupus. 2010 March. Abstract

Infectious Disease

Several studies have shown that regenerative medicine has antimicrobial potential.

Safety and complications reporting on the re-implantation of culture-expanded mesenchymal cells using autologous platelet lysate technique. Centeno CJ. Current Stem Cell Research & Therapy. 2010. Abstract

Antimicrobial properties of mesenchymal cells: therapeutic potential for cystic fibrosis infection and treatment. Sutton MT et al. Stem Cells International. 2016. Abstract

Parkinson's

A study of Parkinson’s patients has demonstrated medium-term improvement with regenerative therapy.

Open-labeled study of unilateral autologous bone-marrow-derived mesenchymal stem cell transplantation in Parkinson-s disease. Venkataramana NK et al. Translational Research. 2010 Feb. Abstract

Organ Transplant

Stem cells have been shown to improve organ acceptance in kidney transplant.

Mesenchymal stromal cells and kidney transplantation: pretransplant infusion protects from graft dysfunction while fostering immunoregulation. Perico N et al. Transplant International. 2013 Sep. Abstract

what is Regenerative Therapy?

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Disclaimer: For Medical Professionals Only

This website is intended to inform and educate medical professionals. It is NOT intended for patients. It also does not seek to make claims about the effectiveness of regenerative medicine and its respective therapies in medical treatment.

Regenerative therapies have great potential in helping treat a range of conditions. This site serves to inform medical professionals about regenerative medicine, BioGenix allograft products, and key in vitro, animal model, and clinical research studies that have been carried out to date across medical specialties and health conditions. However, regenerative medicine is an early and evolving field, and clinical studies are still insufficient to determine effectiveness.

While the BioGenix products are produced in an FDA compliant laboratory, it has not been approved by the FDA for treatment effectiveness. The FDA states:

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.

Patients interested in regenerative therapy in the U.S. are advised to consult a physician about the state of FDA approval for any given product and/or inquire about opportunities to participate in a clinical trial. Patients interested in regenerative therapies outside the U.S. should investigate regulations in the specific country. It is important to be aware that regulations and clinical study requirements vary from country to country.

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