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3141 CURRENT LIMITATIONS IN RPE TRANSPLANTATION ENGELMANN K Dept. of Ophthalmology, University of Hamburg RPE cell transplantation is limited by several factors. The key question is: What are the unsolved problems in RPE cell transplantation? Even if RPE cell transplantation in animal models has been successful, RPE transplantation in humans has failed due to problems associated with the supply of sufficient numbers of differentiated, functional cells. Should primary or cultured cells be used for transplantation? Culturing the cells prior to transplantation is inevitable to obtain sufficient numbers of cells. However, a common known problem in human cell culture is the loss of differentiation. How does the differentiation status of the cells influence transplantation success? Can typical cell functions be maintained? The influence of culture conditions on physiological characteristics, phagocytosis, melanogenesis, vitamin A-metabolism, etc., needs to be investigated. Are the transplanted cells capable of adhering and interacting in the host tissue? A major problem of cell transplantation is the adherence of the cells to the basal substrate, which is altered during retinal degeneration. Strategies to transplant whole sheets or cell suspensions underneath the retina were evaluated. The problems of secondary cell death and degeneration of neighbouring cells are still unsolved. Furthermore, little is known about immunological responses and ageing processes after cell transplantation. Urgent concerns of future studies are therefore maintenance of specific cell functions and differentiation after isolation, during cell culture and after transplantation. To answer all these questions, clinicians and scientists have to combine their efforts for the benefit of the patients.
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CVMP proposal for a List of Substances Essential for the Treatment of Equidae Background The recently amended legislation relating to veterinary medicinal products - Directive 2001 82 EC, as amended by Directive 2004 28 EC - includes specific provisions regarding the treatment of animals of the equine family: Article 10 2 ; provides for the derogation to the application of the general provisions of the so called cascade for food-producing animals under Article 11 of the abovementioned Directive for the treatment for horses provided that the animal concerned has been declared as not being intended for slaughter for human consumption, in accordance with Commission Decisions 93 623 EEC and 2000 68 EC "horse passport" ; . In addition, the provisions in Article 10 3 ; , which are by way of derogation from the provisions of Article 11 of Directive 2001 82 EC, allow the treatment of equidae that are intended for slaughter for human consumption with substances that are essential for their treatment, and a list of such substances shall be drawn up by the Commission for adoption under the comitology procedure. The withdrawal periods to be applied for the treatment with any of the substances from the list shall not be less than six months according to the control mechanisms laid down in Commission Decisions 93 623 EEC and 2000 68 EC. The general provisions for the use of the cascade, i.e. exceptional use under the direct personal responsibility of the responsible veterinarian, do apply. The provisions under Article 10 3 ; are to be understood that they exempt substances allowed to be used under the cascade provisions for food-producing animals under Article 11 of Directive 2001 82 EC, as amended, i.e. substances that are contained in veterinary medicinal products for other food-producing species and are included in Annex I, II or III or Council Regulation EEC ; No 2377 90, and substances included in Annex IV of Regulation 2377 90. The European Commission requested the CVMP to start the preparation of a draft list to be submitted to the Commission. Selection of substances essential for the treatment of equidae As a consequence of the above candidates for the list of essential substances will fall only under the following categories: active substances that are authorised for human use or for use in companion or exotic animals, but are not included in Annex I, II or III of Regulation 2377 90; active substances authorised outside the EU. The term "essential for the treatment of equidae" is understood as no alternative treatment would exist for a therapeutic indication, but allowing also for a therapeutic choice in specific cases, e.g where specific conditions require different medication and or mode of action. Where an alternative for the treatment of a specific condition exists in a veterinary medicinal product that is included in Annex I, II or III of Regulation 2377 90 and is authorised for horses or for other food producing species and could therefore be used under the cascade, a substance cannot be considered as essential even when generally more accepted by veterinarians. Substances for the treatment of chronic diseases that would not allow discontinuing the therapy and do therefore excempt the complience with the minimum withdrawal period of 6 months are not.
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1. Dando, S.A., Chong, S., and Morrison, R.A., Poster Presentation AAPS Meeting 1996. Submitted as manuscript to Pharmaceutical Research, 1997. 2. Howell, S., et al., Biochem J. 284: 595 1992 ; . 3. Rousset, M., et al., J. Cell Phys. 141: 627 1989 ; . 4. Hunter, J., et al., J. Biol. Chem. 286 20 ; : 1491 1993 and
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I have had a difficult time sitting down and trying to put things into words. It is pretty jumbled, but I hope it will help. I think as caregivers - we have to be grateful for each and every moment we have. As overwhelming as the days can seem I don't want to wish them away. In December of 1991 Mom began having difficulty writing, she couldn't explain it but she just didn't seem to be able to write well. She then started to develop a tremor in her right hand. and her speech started to slur. She was first diagnosed at the Mayo Clinic, in Rochester, MN. In July 1994. Increased tremor which has also now shown up in the left hand, inability to control speech, body movements, alien limb, occasional double vision seemed to go along with some of the medication ; . Mom can think of something she wants to say but then it doesn't come out of her mouth. She can't recall numbers, letters, dates, etc. She knows them in her head but can't speak them. She often says yes for no and vise versa. She is unable to write. She has great difficulty feeding herself due to tremors and lack of motor control in the limbs. She shuffles when she walks and tends to bump into things on her right. She has had numerous falls. She has had some difficulty with swallowing but that seems a bit better. She also has frequent loss of bladder and bowel control. She can no longer dress or bathe herself. I stitched the buttons on her blouses with elastic thread so they would be buttoned but she could slip them on and off. We sewed Velcro to some of her buttons, and bought all pants with elastic waste as she can't work zippers, buttons, etc. We also bought elastic shoe laces. She wears supportive tennis shoes and with the elastic, they don't have to be tied. Mom has a wonderful physical therapist. Medicare refused to cover the therapy any more because there was no improvement. We strongly feel the physical therapy helped-- Her therapist continued to treat Mom weekly on her own time. In addition she does speech therapy and occupational therapy. Equipment: We have a LaBoudet for the bathroom, Mom has great difficulty wiping and this helps. She has a swivel spoon to feed herself, a motorized ; recliner chair with a button to raise the chair to get in or out, a medical alert button which works GREAT ; . The occupational therapist made a special splint for her right hand to help the rigidity of the hand and the thumb.
2 Levit K, Smith C, Cowan C, Lazenby H, Sensenig A, Catlin A. Trends in U.S. health care spending, 2001. Health Affairs. 2003; 22 1 ; : 154-164. 3 ibid. 4 Centers for Medicare and Medicaid Services, Office of the Actuary; and the U.S. Department of Commerce, Bureau of Economic Analysis and Bureau of the Census, as cited in: Heffler S, Smith S, Keehan S, Clemens MK, Won G, Zezza M. Health care spending projections for 2002-2012. Health Affairs-Web Exclusive. No Date Given. Available at: : healthaffairs WebExclusives 2202Heffler . Accessed January 2003 and
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145. Neususs K, Neumann B, Steinhoff BJ, Thegeder H, Bauer A, Reimers D. Physical activity and fitness in patients with headache disorders. Int J Sports Med 1997; 18: 607611. Marcus DA, Scharff L, Mercer S, Turk DC. Nonpharmacological treatment for migraine: incremental utility of physical therapy with relaxation and thermal biofeedback. Cephalalgia 1998; 18: 266-272. Diener HC, Kronfeld K, Boewing G, et al. Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial. Lancet Neurol 2006; 5 4 ; : 310-6. 148. Linde K, Streng A, Jurgens S, et al. Acupuncture for patients with migraine: a randomized controlled trial. Jama 2005; 293 17 ; : 2118-25.
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