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Cellular Therapy

Stephen Barrett, M.D.

Cellular therapy -- also called live cell therapy, cellular suspensions, glandular therapy, fresh cell therapy, siccacell therapy, embryonic cell therapy, and organotherapy -- refers to various procedures in which processed tissue from animal embryos, fetuses or organs, is injected or taken orally. Products are obtained from specific organs or tissues said to correspond with the unhealthy organs or tissues of the recipient. Proponents claim that the recipient's body automatically transports the injected cells to the target organs, where they supposedly strengthen them and regenerate their structure. The organs and glands used in cell treatment include brain, pituitary, thyroid, adrenals, thymus, liver, kidney, pancreas, spleen, heart, ovary, testis, and parotid. Several different types of cell or cell extract can be given simultaneously -- some practitioners routinely give up to 20 or more at once [1].

The first recorded attempt at cellular therapy occurred in 1912 when German physicians attempted to treat hypothyroid children with thyroid cells [2]. Cellular therapy, as practiced today, was developed in the early 1930s by Paul Niehans, MD (1882-1971), a Swiss physician who became known as "the father of cell therapy." [2] It soon became popular with celebrities as a means of rejuvenation. A 1990 article in In Health magazine described Niehans as a "public relations genius" and stated that the Clinique La Prairie, which he had founded in Clarens-Montreaux, Switzerland, had attracted 65,000 patients [3]. Its current (1999) one-week "revitalization program" costs about $8,000.

Another notorious practitioner was John R. Brinkley, commonly referred to as "the goat gland doctor," an American diploma-mill "graduate," who reportedly did 16,000 operations in which he implanted men with tissue from the testicles of young goats [4]. Brinkley asserted that his procedure was not only effective against impotence and infertility, but could also cure conditions ranging from insanity and acne to influenza and high blood pressure. Brinkley began operating in 1917. The American Medical Association eventually persuaded the Kansas Board of Medical Registration to revoke his license on the grounds of immorality and unprofessional conduct. Brinkley was indicted for mail fraud in 1941 and died about nine months later [5].

In 1970, Wolfram Kühnau, MD, an associate of Dr. Niehans, began using cellular therapy to treat cancer patients in Tijuana, Mexico. It is also claimed to build the immune system and help patients with Down's syndrome, Alzheimer's disease, epilepsy, AIDS, and various other diseases.

A naturopath named James L. Wilson has been promoting the use of products made from bovine mesenchymal cells. (Mesenchyme is a type of embryonic connective tissue.) According to Wilson, the cells "have the ability to migrate to any tissue in need of repair and, once at the site, take on the characteristics of the healthy cell it associates with." [6]. Wilson even claims that a mesenchymal product can be administered under the tongue. Studies have been done -- mainly in laboratory preparations -- in which mesenchymal stem cells demonstrate reparative ability when placed directly in contact with certain tissues [7]. However, it is absurd to believe that they can migrate to where they are needed in the body. Moreover, when taken orally, they are digested and can exert no significant effect on body function.

The Grim Reality

The theory behind cellular therapy is senseless. The American Cancer Society has strongly advised people not to seek it [8]. Under ordinary circumstances, cells from the organs of one species cannot replace the cells from the organs of other species. When foreign proteins are injected, the immune system attacks them. In addition, injections of animal cells can spread viral disease and trigger severe allergic reactions. When taken by mouth, animal cells are digested and are not absorbed intact into the body. The adverse reports include:

In the mid-1960s, a federal court approved the destruction of several small shipments of Niehans cellular products that had been shipped to New York City by companies from Germany and Switzerland [19], In 1984, the FDA banned importation into the U.S. of all cellular powders and extracts intended for injection [20]. In 1987, the Federal Health Office of West Germany suspended the product licenses of 235 whole-cell preparations made by four pharmaceutical companies [16]. In 1996, the FDA warned against "Zellen-Cell Therapy" pills, which a Mexican company was marketing for arthritis, asthma, chronic fatigue, diabetes, hormonal disturbances, sexual dysfunction, degenerative brain disease, osteoporosis, and other conditions. The company's solicitation included a memo from "Dr. Hanz Byron, Premature Aging Specialist." [21]

In 1987, Australian researchers reported on a study which compared children with Down syndrome who received cell therapy with similar children who did not. The study found no evidence that the cell therapy was effective [22]. In 1990, another Australian physician reported that cell therapy had failed to help a 34-year-old woman who had entered a become quadriplegic after a horseback riding accident. Blood tests found no evidence of that the woman had formed antibodies to animal cells that supposedly were in the cell preparation, which means that the preparation used might not have contained any cells [23].

A malpractice suit involving cellular therapy was filed against Gabriel Cousens, M.D., a homeopathic physician who operates the Tree of Life Regeneration Center, in Patagonia, Arizona. The complaint stated that Cousens had treated Charles Levy over a 5-day period in 1998, during which time Levy developed and died from a Clostridium perfringens infection (gas gangrene) caused by injections with "bovine adrenal fluid." [24] The case was settled by an out-of-court settlement that included payment of an undisclosed amount of money.

In 2003, the FDA issued a letter ordering Target Your Health, Inc., of Wildomar, California, to stop making illegal claims that its Live Cell Growth Factors, which are derived from cells from sheep or cattle embryos, "have the potential to adapt and heal organs or body tissue in need of repair." The product line includes "Embryoblaste," "Artery," "Cartilage," "Whole Brain," "Muscle," "Eye," "Pancreas," "Skin," "Lung," "Spleen," "Kidney," "Heart," "Whole Embryo," "Liver," "Pituitary Gland," "Hypothalamus," "Intestine," "Spinal Cord," "Bone Marrow," "Adrenal Gland," "Testis," "Thymus," "Vessel," and "Vein." The warning letter notes that that the intended use of the products makes them unapproved new drugs that cannot be legally marketed without FDA approval. The company also advertised that the cells are "removed from animals in approved slaughterhouses that have passed all health controls" and that "the veterinary controls certify that the animals are healthy, suitable for human consumption and free of any spongiform encephalitis." Calling attention to restrictions on the use of animal-derived tissues in certain biological products, the FDA also warned that biologic products cannot be legally marketed without a license issued after a showing that the product is safe and effective for its intended use [25] The claims to which the FDA objected have been removed from the company's Web site but can be viewed in the Internet Archive.

References

  1. Gelband H and others. Cellular treatment. In Gelband H and others. Unconventional cancer treatments. Washington, DC, U.S. Government Printing Office, 1990. pp 97-98.
  2. Kuettner H. Verimpfung an stelle der transplantation hochwertiger organe. Zentralblatt fur Chirugie 1:390-397, 1912., as cited in Popov IM and others. Journal of the International Academy of Preventive Medicine 40:74-82, 1977.
  3. Tierney J: Buying time. In Health 4(1):35-44, 1990.
  4. The goat gland doctor. In Schwarcz J. The Genie in the Bottle. Toronto: ECW Press, 2001.
  5. Hafner AW and others, editors. Guide to the American Medical Association Historical Health Fraud and Alternative Medicine Collection. Chicago: American Medical Association, 1992.
  6. Wilson JL. Mesenchyme: Little known rejuvenating healer. Feb 15, 2000.
  7. van den Bos C and others. Human mesenchymal stem cells respond to fibroblast growth factors. Human Cell 10:45-50. 1997.
  8. Unproven methods of cancer management: Fresh cell therapy. CA -- A Cancer Journal for Clinicians 41:126-128, 1991.
  9. Lindeman B, Cubbison C: Cellular therapy: A shabby clinic offered rejuvenation but delivered death. Today's Health 53:36-41, 1975.
  10. Osband ME and others. Histiocytosis-X. Demonstration of abnormal immunity, T-cell histamine H2-receptor deficiency, and successful treatment with thymic extract. New England Journal of Medicine. 304:146-153, 1981.
  11. Kiefer H and others. Ascending polyradiculitis following swine brain implant in a patient with encephalomyelitis disseminata. Nervenarzi 55:422-425, 1984.
  12. Armoni M and others. Siccacell therapy in Down's syndrome. Harefuah 108:64-68, 1985.
  13. Susei Z, Swarc M. Guillain-Barré syndrome after injection of sheep cells. Harefuah 114:536-538, 1988.
  14. de Ridder M and others. Two cases of death following cell therapy. Deutsche Medizinische Wochenshrift 112:1006-1009, 1987.
  15. Goebel HH and others. Fresh cell therapy followed by fatal coma. Journal of Neurology 233:242-247, 1986.
  16. Saurat, J-H and others. Blistering skin disease in a man after injections of human placental extracts. British Medical Journal 297:775, 1988.
  17. Bohl J and others. Complications following cell therapy. Zeitschrift fur Rechtsmedizin 103:1-20, 1989.
  18. Cell therapy suspended. Lancet, Aug 29, 1987, p 503.
  19. Wobe enzymes and prepared animal tissues. DDNJ 8083, Food and Drug Administration Notices of Judgment, Aug 1965, p 431, as cited in 1971 American Cancer Society position paper on fresh cell therapy.
  20. Cell therapy. FDA Talk Paper T84-78. Rockville, MD: Food and Drug Administration, Nov 5, 1984.
  21. FDA Import Alert #66-41. Unapproved New Drugs Promoted In the U.S. Revised 8/9/95, 8/4/99.
  22. Foreman PJ, Ward J. An evaluation of cell therapy in Down syndrome. Australian Paediatric Journal 23:151-156, 1987.
  23. Last PM. Cell therapy: A cruel and dangerous deception. A drama in three acts. Journal of Paediatrics and Child Health 26:197-199, 1990.
  24. Plaintiff's initial disclosure statement. Howard Levy vs Dr. Gabriel Cousens, No. 333704, Superior Court for the State of Arizona in and for the County of Pima, filed Oct 13, 1999.
  25. Masiello SA. Warning letter to Gisella Thomas, Sept 27, 2003.

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This article was revised on August 21, 2003.