Isolagen 

The Isolagen anti-aging process uses a patient's own collagen-producing cells to produce results that are long lasting and highly effective.

“The Isolagen Process is not yet approved by FDA”

Overview

Isolagen, Inc., founded in 1995 and located in Houston, Texas, has become an emerging force in biotechnology by specializing in the development and commercialization of its autologous cellular system (ACS) technology.

With four secured patents and an additional patent pending, the Isolagen Process represents a unique breakthrough in ACS technology in the overall approach to cosmetic and medical therapy. Specifically, the Isolagen Process has applications in cosmetic dermatology, cosmetic surgery, periodontal disease, and reconstructive dentistry, among other therapies.

The Isolagen Process is a novel process whereby a patient’s own collagen-producing cells (fibroblasts) are extracted, reproduced, and then re-introduced by injection back into the patient’s treatment area. Unlike other collagen development companies, Isolagen uses only the patient’s unique, living cells to produce the patient’s own collagen. There is no foreign substance utilized in this treatment protocol, and the results are significantly longer lasting than other techniques. Isolagen’s vision is to be the industry leader in the research, development and commercialization of ACS tissue regeneration.

Mission Statement

Maintain leadership in research, development and commercialization of non-invasive autologous fibroblast cellular therapies.

History

In the early 1990’s, premier cell biologist Olga Marko began investigating the use of technology for stimulating a patient’s own cells to produce collagen. Research of this nature was then not yet regulated by the FDA. Through her research, Ms. Marko developed a process of extracting a patient’s own collagen-producing cells (dermal fibroblasts), growing and expanding those cells in a controlled environment, and then re-introducing the fibroblasts by injection into the skin of the patient’s face. Once injected, it was believed that the fibroblasts produced collagen which might prove to be beneficial in the repair of dermal defects. This research lead to the development of the Isolagen Process (ACS - Autologous Cellular System). At this time, the ACS process could be legally marketed.

In December 1995, with the support of William K. Boss, Jr., M.D., a board certified plastic surgeon, Isolagen Technologies was formed for the purpose of researching, developing, marketing and commercializing the Isolagen Process for cosmetic applications. During 1995, Dr. Boss began treating dermal defects (i.e., wrinkles, depressions, and scarring) in a limited number of his patients with the Isolagen Process.

Dr. Boss and Ms. Marko soon solicited the clinical support of Gregory Keller, M.D., Associate Chief, Head and Neck Plastic Surgery at the University of California, Los Angeles Medical School and W. Gregory Chernoff, M.D., a plastic surgeon with practices in California and Indiana. Between 1995 and 1999 Drs. Boss, Keller and Chernoff, together with about 200 other doctors, used the Isolagen Process approximately 3,400 times on approximately 1,100 patients. The worst reactions observed were redness at the injection site lasting about a week.

In 1999 the FDA started to regulate marketing of these types of products, and instructed Isolagen to stop marketing its ACS products. Isolagen filed an IND which is now approved.

All the above described procedures were performed at least three years ago, and some as long as seven years ago. Isolagen is currently planning a study to determine whether patients still report a high level of satisfaction with their results. Unlike other available treatments, the Isolagen Process does not involve animal collagen or any foreign substances. The Isolagen Process utilizes a patient’s own cells for producing the patient’s own collagen. In this way, Isolagen hopes to show that the incidence of allergic reaction or rejection may be reduced to a minimum or even eliminated entirely. Also, Isolagen is collecting data to demonstrate whether the treatment effect is longer lasting than with other treatment techniques, with patients experiencing continued, gradual improvement over time. It seems Isolagen may have developed the first truly ”all natural” tUS Scientific Advisory Board

Rena N. D’Souza, PhD, DDS, MS.
Prof. & Dir. of Research Department of Orthodontics
The UofT, Dental Branch, Houston, TX

Otis Bouwsma, PhD, DMD.
Assoc.Prof./Dir., Advanced Ed. Program in Periodontics
The UofT Health Science Center, Dental Branch, Houston, TX

James T. Mellonig, DDS, MS.
Prof., Head Specialist Div. & Dir. of Advanced Ed. Program
The UofT Health Science Center, San Antonio, TX

Jack G. Caton, Jr., DDS, MS.
Prof., Eastman Dept. of Dentistry, & Chief, Div. of Periodontics
UfR Eastman Dental Center, Rochester, NY

Nicolas Elian, DDS.
Dir. of the International Residency Program in Implant Dentistry
(NYU) College of Dentistry, Chief Attending Prosthodontist at Peninsula Hospital Center & Dir. of The General Practice Residency at Peninsula Hospital Center

European Scientific Advisory Board

Prof. Maurizio Tonetti DMD, PhD, MMSc, FDS, RCPS.
Prof. of Periodontology, UC London, England
Head of Periodontology, Eastman Dental Clinic., London

Prof. Colin Green PhD, DSc (Med), FRCVS, FRCPath, FRCS (hon).
Dir. of the Northwick Park Institute of Med.Research, London, England, & Head of Surgical Research

Nicholas J. Lowe, MD, FRCP, FACP.
Clinical Prof. Dermatology, UCLA School of Med., LA, CA & Sen. Lecturer in Dermatology, UCLA School of Med., London, England

John B. Pring
Technical Dir. at Kryotrans, London, England

Claire Linge, PhD.
Senior Scientist in RAFT Institute of Plastic Surgery &
Dir. of Wound Healing Group, London, England

US Scientific Advisory Board

Rena N. D’Souza, PhD, DDS, MS. is Professor and Director of Research Department of Orthodontics, The University of Texas, Dental Branch, Houston, TX. Dr. D’Souza received her Bachelor of Dental Surgery from the University of Bombay, India, her D.D.S. Advanced Standing Program from The University of Texas Health Science Center, Dental Branch, Houston and both her Ph.D. and M.S. from The University of Texas Health Science Center, Houston. She has held several editorial positions and received numerous awards and honors. She continues to serve on national and international service groups and committees.

Otis Bouwsma, PhD, DMD. is Associate Professor/Director, Advanced Education Program in Periodontics at The University of Texas Health Science Center, Dental Branch at Houston, TX. Dr. Bouwsma received his M.S. from Northeast Louisiana University; his Ph.D. from the University of Georgia Graduate School; and his D.M.D. from the University of Mississippi School of Dentistry. He has served on specialty boards with the American Board of Periodontology and the American Academy of Periodontology. Dr. Bouwsma has been a representative to the Dental Device Panel of the U.S. Food and Drug Administration (FDA) and has been Principal Scientist and Senior Scientist to Johnson & Johnson, Inc. and Proctor & Gamble, Inc., respectively. He has received numerous honors and awards; and he has published articles for journals, abstracts, book chapters, manuals and teaching aids.

James T. Mellonig, DDS, MS. is Professor, Head Specialist Division and Director of Advanced Education Program at The University of Texas Health Science Center, San Antonio, TX. Dr. Mellonig received his D.D.S. from Marquette University and his M.S. from George Washington University. Dr. Mellonig was the Chairman of the Department of Periodontology, as well as Professor, Director Postgraduate Periodontics and Specialty Advisor to the Naval Medical Command, Navy Dental School. He has served as the President of the American Academy of Periodontology and he has received numerous honors and awards. He has served on several editorial boards and he has published articles, abstracts and books/chapters.

Jack G. Caton, Jr., DDS, MS. is Professor, Eastman Department of Dentistry, and Chief, Division of Periodontics University of Rochester Eastman Dental Center, Rochester, NY. Dr. Caton received his D.D.S. from the University of California Dental School and his M.S. from the University of Rochester. Dr. Caton has served as President of the American Academy of Periodontology. He has also been a consultant, served on numerous committees, and written numerous abstracts.

Nicolas Elian, DDS. is Director of the International Residency Program in Implant Dentistry at New York University College of Dentistry, (NYU) Chief Attending Prosthodontist at Peninsula Hospital Center, and Director of The General Practice Residency at Peninsula Hospital Center. Dr. Elian received his DDS from NYU College of Dentistry in 1991 with Honors in Fixed Prosthodontics, the Academy of Dentistry for the Handicapped Certificate of Recognition for High Achievement in the Undergraduate Curriculum in Dental Care for the Handicapped, and the Dr. Arthur N. Caplin Scholarship Award in Recognition of Outstanding Academic Achievement in the Discipline Removable Prosthodontics. In 1993 he received his certificate in prosthodontics. In 1995, he completed his fellowship in implant dentistry. Dr. Elian is involved extensively in the field of tissue engineering, distraction osteogenesis, and esthetic implant design. His work on ridge splitting and grafting presented at the 2001 Annual Academy of Osseointegration Meeting was the recipient of Best Table Clinic Award. Dr. Elian is an investigator on several research projects at NYU; and he also participates in multi-center studies, involving such institutions as The Harvard School of Dental Medicine, and The University of North Carolina. Dr. Elian frequently lectures on a variety of topics related to implant dentistry.

European Scientific Advisory Board

Professor Maurizio Tonetti DMD, PhD, MMSc, FDS, RCPS. is Professor of Periodontology, University College London, England, and Head of Periodontology, Eastman Dental Clinic., London. Professor Tonetti is considered one of the top periodontologists in Europe. He has pioneered and perfected several novel treatment approaches in periodontology and Implant dentistry. His research interests include tissue engineering, matrix scaffolds and bioengineering processes. He is currently appointed as Visiting Professor of Periodontology at the University of Berne, Switzerland and the University of North Carolina USA.

Professor Colin Green PhD, DSc (Med), FRCVS, FRCPath, FRCS (hon). is Director of the Northwick Park Institute of Medical Research, London, England, and Head of Surgical Research. Dr. Green is a professor of Surgical Science in University College London, and UNESCO Professor of Cryobiology in the Ukraine Academy of Science. He has over 32 years experience in organ transplant biology and low temperature biology. He has published extensively in the area of wound healing and tissue engineering. His international collaborations include projects in Russia, Ukraine, Singapore, the Middle East and Europe.

Nicholas J. Lowe, MD, FRCP, FACP. is Clinical Professor Dermatology, UCLA School of Medicine, Los Angeles, CA, and Senior Lecturer in Dermatology, UCLA School of Medicine, London, England. Dr. Lowe has published over 350 clinical and research publications and abstracts. Dr. Lowe has edited, written and published 15 books. Dr. Lowe serves on the editorial board of numerous international medical journals and is a founding editor of the Journal of Cutaneous Laser Therapy.

John B. Pring. is Technical Director at Kryotrans, London, England. Mr. Pring received his diploma from the Royal Colleges of Surgeons and Physicians in the Sciences Basic to Medicine. He was a Director of the National Institute for Biological Standards and Controls and the National Biological Standards Board, appointed by the Ministry. Mr. Pring has over 30 years experience at the National Institute for Biological Standards and Control (U.K.), specializing in quality systems for such products as vaccines and blood. His special interests include cell biology, tissue engineering and low temperature transportation and tracking of Biologics. He is also experienced in ISO 9001 and other biological standards relevant to Isolagen’s global market.

Claire Linge, PhD. is Senior Scientist in RAFT Institute of Plastic Surgery and Director of Wound Healing Group, London, England. Dr. Linge gained her P.hD. at the University of London on the expansion ex vivo of cultured keratinocytes and cell-cell interactions in cancer. Dr. Linge has 18 years experience in human cell biology. She is a specialist in the growth of fibroblasts for burn casualties. She also has extensive experience in growing keratinocytes; and she is currently investigating the control of scarring, melanomas, laser depilation and tissue repair. In addition, Dr. Linge has specific experience in the design and equipage of large cell expansion laboratories.reatment for aging and scarred skin.

Contacts

US Corporate Headquarters:
Belinda Long, Customer Relations
Isolagen, Inc.
2500 Wilcrest, 5th Floor
Houston, TX 77042
Phone: 713-780-4754
Fax: 713-781-9396
Email: blong@isolagen.com

UK office:
Brian Whitley, President and CEO
Isolagen Europe Ltd.
500 Chiswick High Road
London, England W4 5RG
Phone: 44 (0) 20 8956 2486
Fax: 44 (0) 20 8956 2488
Email: infouk@Isolagen.com

Dermatological

The Isolagen process in detail

Isolagen’s patented autologous (a patient’s own cells) living cell therapy, or ACS, begins with the injection of a local anesthetic to numb a small section of skin behind the ear. This area was chosen because of its vascularity, lack of sun exposure, and the invisibility of any scarring.

A simple punch biopsy is used to obtain a small 3 mm piece of skin tissue, which is packed in an appropriate container and shipped overnight to the Isolagen laboratories. The minimal incision is closed with an adhesive or single absorbable suture.

At Isolagen, the tissue is cultured utilizing Isolagen’s patented ACS process. This process separates collagen-producing cells, called fibroblasts, from the rest of the tissue then stimulates them to multiply into tens of millions of new cells.

After approximately six weeks, 1 to 1.5 ml of cultured fibroblasts are sent back to the doctor for injection into the patient’s wrinkles, lines, and scars.

Generally three sets of injections will be performed, about two weeks apart, with tens of millions of collagen-producing cells being injected during each visit.

Within the patient’s skin, it is believed that the injected fibroblasts will continue to multiply and create new collagen that may fill dermal imperfections and wrinkles, and may reduce the signs of aging.

Cryogenic storage of cultured cells may also permit patients to receive future treatments with cells that were harvested when the patient was younger. It is unknown at this time whether this would represent a benefit to patients.

Benefits of facial rejuvenation

Since the Isolagen Process is an autologous system (exclusively using a patient’s own cells), it is anticipated that there may be a substantially reduced possibility of allergic reaction as compared to bovine collagen and other non-natural fillers.

Isolagen hopes to demonstrate that the use of autologous cells will result in prolonged beneficial effects, as the immune system should not reabsorb or reject them as it might with foreign materials and proteins. Patients may experience gradual and continued improvement as a result of the natural activity of the re-introduced cell structure.

Considering that the standard until recently has been bovine collagen, the three potential benefits below may represent substantial advances in facial rejuvenation.

1. Bovine collagen, a foreign protein derived from cows, is generally fully reabsorbed by a patient’s body within a few months after application, leaving the patient with no visible signs of correction.

2. As additional treatments with bovine collagen are performed, there is a gradual build-up of the body’s antibodies and the development of enzymes that compromise the treatment’s effectiveness.

3. Combined with the expense and the continued intrusiveness of ongoing treatments, the value and benefit of bovine collagen injections is ultimately diminished

FAQ

What is collagen?
Collagen is a naturally occurring protein that constitutes one of the primary components of the dermis, or second layer of the skin. Collagen forms a network of fibers that gives the skin structure and support. The specialized cells in the skin responsible for forming collagen are called fibroblasts.

Why do lines occur?
The appearance of lines is primarily caused by a reduction in the number of active fibroblast cells in the dermis. As these collagen-forming cells gradually diminish, the skin’s support system is weakened and the signs of aging begin to appear.

What does the treatment involve?
The Isolagen treatment starts with a simple biopsy procedure to take a small 3mm piece of skin tissue from behind the ear. A local anesthetic is given (such as might be administered at the dentist’s) and then the tissue is quickly removed and a single absorbable suture or adhesive dressing is used to close the wound. The skin tissue is then sent to Isolagen where our patented cell expansion process is used to stimulate the cells to reproduce into tens of millions of new fibroblasts. After about 8 weeks, the cells will be sent back to the treating physician’s office where the patient will receive a series of therapeutic injections with a very small needle. Two additional treatments are generally administered, about two weeks apart, which will also utilize cells that have been grown from the culture system initiated by the originally removed tissue. There is no need for further biopsies.

Is the process painful?
The procedure is well tolerated and very similar to a typical injection. Should discomfort be anticipated, the surgeon can apply a topical anesthetic cream that will reduce the sensation of the needle. In very sensitive areas, such as around the lips, a local anesthetic can also be given by injection.

Are there any side effects?
Patients may experience some reddening and soreness around the injection sites, which usually fades after about a day. In over 1200 patients treated, there have been only a few cases of slight hypersensitivity to the injection.

Are the effects immediate and how long does treatment last?
It is expected that patients will see a continuous gradual improvement over about a year, but this has not yet been proven.

How many repeat injections are needed?
This has not yet been scientifically established. Isolagen anticipates that a course of three injections will be adequate, however in cases where the wrinkles are very deep, extra sessions may be required. Further stimulation with micro-dermabrasion, lasers, chemical peels, and ultrasonic facials may be helpful in maximizing the results. Irrespective of the number of injections, only one sample of tissue usually needs to be taken, as the cultured cells can be stored cryogenically for future treatments.

Are additional treatments possible?
No patients have received more that one course of treatments with the Isolagen ACS system, so no scientific data is currently available, however there is no reason to believe that repeat treatments will not be possible.

Can cells be stored for future use?
The potential for cryogenic preservation of cultured cells is one of the advantages of the Isolagen process. Once tissue has been cultured in the laboratory it can be stimulated repeatedly to produce millions of new cells. These cells can be stored for prolonged periods for future use.

Can the Isolagen treatment be used with other laser therapies like non-ablative lasers, Cooltouch and Enlight?
Isolagen intends to investigate this in the future.

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For additional information on this Medical Research article, please contact:

Henry Mentz, MD, FACS, FICS / The Aesthetic Center For Plastic Surgery
(877) 707-2277

Source: Dr. Mentz
http://www.drmentz.com

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