Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing
Reexamination Certificate
1998-10-07
2004-03-30
Wilson, Michael (Department: 1633)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Reexamination Certificate
active
06713054
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not applicable.
BACKGROUND OF THE INVENTION
The present invention relates to chronic fatigue syndrome (“CFS”) and more particularly to a novel cellular therapy treatment thereof.
CFS is characterized by debilitating fatigue that is not attributable to known clinical conditions, that has lasted for over 6 months, that has reduced the activity level of a previously healthy person by greater than 50%, and that has been accompanied by flu-like symptoms (e.g., pharyngitis, adenopathy, low-grade fever, myalgia, arthralgia, headache) and neuropsychological manifestations (e.g., difficulty concentrating, exercise intolerance, and sleep disturbances). Klimas, et al., “Chronic Fatigue Syndrome”,
Curr. Opin. Inf. Dis
., 8:145-148 (1995); Buchwald, et al., “Chronic illness characterized by fatigue, neurologic and immunologic disorders and active human herpesvirus 6 type infection”,
Ann. Int. Med
., 116:103-113 (1992); Millon, et al., “A psychological assessment of chronic fatigue syndrome/chronic Epstein-Barr virus patients”,
Psychol. Health
., 3:131-141 (1989); Lutgendorf, et al., “Relationships of cognitive difficulties, depression and illness burden in chronic fatigue syndrome”,
J. Chronic Fatigue Syn
., 1:23-41 (1995); Fukuda, et al., and the International CFS Study Group, “The Chronic Fatigue Syndrome: A comprehensive approach to its definition and study”,
Ann. Intern. Med
., 121:953-959 (1994), Klimas, et al., “Chronic Fatigue Syndrome”,
Curr. Opin. Inf. Dis
., 8:145-148 (1995). CFS frequently is of sudden onset. Possible precipitating events include, for example, infections, psychiatric trauma, and exposure to toxins. Klimas, “Chronic fatigue syndrome and psychoneuroimmunology”,
In Stress and Disease Progression: Perspectives in Behavioral Medicine
”, Schneiderman, et al., eds., Lawrence Erlbaum, Assoc., Hillsdale, NJ, pp. 121-137 (1992); Chester, et al., “Concurrent sick building syndrome and chronic fatigue syndrome”.
Clin. Inf. Dis.
., 18 (suppl. 1):S43-48 (1994): Ablashi, et al., “Viruses and chronic fatigue syndrome: Current status”,
J. Chronic Fatigue Syn
., 1:3-22 (1995).
The definition adopted by the Center for Disease Control and Prevention is set forth in Fukuda, et al., and the International CFS Study Group, “The Chronic Fatigue Syndrome: A comprehensive approach to its definition and study”, supra. For further information and articles on CFS, reference is made to the CDC website located at www.cdc.gov
cicdod/disease.cfs. It should be noted that a related illness closely associated with CFS is fibromyalgia syndrome (“FMS”), because of its substantial symptom overlap with CFS. Further information on FMS can be found from, for example, the Fibromyalia Network at www.fmnetnews.com (Fibromyalgia Network, Tucson, Ariz.). Often, patients presenting with CFS also will be diagnosed with FMS.
Despite the studies reported above and others, both the cause and treatment of CFS and FMS remain beyond the grasp of present-day medicine. The present invention, however, will change these unknowns by providing a treatment for CFS and FMS that has been shown to materially offer hope to those afflicted by this debilitating condition.
BRIEF SUMMARY OF THE INVENTION
The present invention relates to the treatment of CFS and FMS that exploits the effective cellular immune response that is initially generated in CFS individuals. One aspect is a method for preparing cells for treating patients afflicted with CFS, which includes subjecting cells derived from lymph nodes excised from patients afflicted with CFS to mitogenic stimulation in serum-free media for their expansion. The resulting therapeutic agent for treating patients afflicted with CFS includes in a pharmaceutically-acceptable carrier, cytokine-producing cells having been produced by the step of subjecting cytokine-producing cells derived from lymph nodes excised from patients afflicted with CFS to mitogenic stimulation in serum-free media for their expansion.
As another aspect of the present invention, disclosed is a method for treating patients afflicted with CFS that includes administering to the patient an effective amount of the therapeutic agent disclosed herein. The invention also is capable of treating individuals afflicted with fibromyalgia syndrome (“FMS”).
Finally, the invention further is effective in lowering activated T cell count in individuals where an activated T cell count is inappropriate (an immunologic abnormality), such as, for example, in CFS patients. See, for example, Cannon, et al., “Interleukin-1 beta, interleukin-1 receptor antagonist, and soluble interleukin-1 receptor type II secretion in chronic fatigue syndrome”,
J Clin Immunol
, 1997 May; 17(3): 253-61; and Hassan, et al., “A study of the immunology of the chronic fatigue syndrome: correlation of immunologic parameters to health dysfunction”, Clin Immunol Immunopathol, 1998 Apr, 87(1): 60-7. Such lowering of activated T cell count would appear to be a response evoked by the course of treatment disclosed herein for other disease conditions as well as CFS.
Advantages of the present invention include a culture procedure that is easy, expedient, and reproducible. Another advantage is a therapeutic agent that moderates many of the debilitating symptoms associated with CFS. A further advantage is that total lack of adverse side effects when using the novel therapeutic agent. These and other advantages will be readily apparent to those skilled in the art.
REFERENCES:
Levine et al. Am. J. Med., vol. 105, pp. 100S-103S, Sep. 28, 1998.*
Caplan, Can. Med. Assoc. J., vol. 159, pp. 519-520, Sep. 8, 1998.*
Goldberg, Curr. Op. in Rheum., vol. 9, pp. 135-143, Mar. 1997.*
Peakman et al. Clin. Immuno. and Immunopath., vol. 82, pp. 82-91, Jan. 1997.
Cira Technologies, Inc.
Mueller and Smith LPA
Wilson Michael
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