Food and Drug Administration

Center for Biologics Evaluation and Research

Cellular, Tissue and Gene Therapies Advisory Committee

Meeting, March 14, 2009

 

Bibliography

 

Topic I:  Potential for Chlamydia trachomatis and Neisseria gonorrhoeae transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are recovered from the reproductive system, gestational tissues, or other sources.

 

Arko, R.J. and Wong, K.H. (1977) Comparative physical and immunological aspects of the chimpanzee and guinea-pig subcutaneous chamber models of Neisseria gonorrhoeae infection. Br J Vener Dis,  53, 101-105.

 

Arko, R.J. (1989) Animal models for pathogenic Neisseria species. Clinical Microbiology Reviews, April, 556-559.

 

Barry, W.C., Teare, E.L., Uttley, A.H.C., Wilson, S.A., McManus, T. J., Lim, K.S., Gamsu, H. and Price, J.F., Chlamydia trachomatis as a cause of neonatal conjunctivitis.

 

Darville, T., (2008) Chlamydia trachomatis. Long: Principles and Practice of Pediatric Infectious Diseases, 3rd ed., Elsevier, Chap. 167.

 

Djukic, S., Nedeljkovic, M., Pervulov M., Ljubic, A, Radunovic, N. (1996) Intra-amniotic Chlamydia trachomatis infection.  Gynecologic and Obstetric Investigation, 42(2), 109-12.

 

Frost E., Leclerc, A., Gioanni, G., Goeman, J., Peeters, M., Collet, M. (1988) Chlamydia infect the placenta less often that gonococci. Genitourin Med, 64, 349-50.

 

Gencay, M., Puolakkainen, M., Wahlstrom, T, Ammala, P., Mannonen, L., Vaheri, A and

Koskiniemi, M.L. (1997) Chlamydia trachomatis detected in human placenta. J. Clin. Pathol., 50, 852-855.

 

Gerecht-Nir, S, Itskovitz-Eldon, J. (2004) Cell therapy using human embryonic stem cells. Transplant Immunology, 12, 203-209.

 

Givner, L.B., Rennels, M.B., Woodward, C.L., Shih-W-H. (1981) Chlamydia trachomatis infection infant delivered cesarean section. Pediatrics, 68, 420-421.

 

Goldenberg, R.I., Culhane, J.F., Iams, J.D., Romero, R. (2006), Epidemiology and causes of preterm birth, Lancet, 372, 75-84.

 

Harrison, H.R., Riggin, R.T. (1979) Infection of untreated primary human amnion monolayers with Chlamydia. J Infect Dis, 140, 968-71.

 

Heckels, J.E., Blackett, B., Everson, J.S., Ward, M.E. (1976) The influence of surface charge on the attachment of Neisseria gonorrhoeae to human cells. J Gen Microbiol, 96, 359-64.

 

Hida, N., Nishiyama, N., Miyoshi, S., Kira, S., Segawa, K., Uyama, T., Mori, T., Miyado, K., Igegami, Y., Cui, C., Kiyono, T., Kyo, S., Shimizu, T., Okano,T., Sakamoto, M., Ogawa, S., Umezawa, A. (2008) Novel cardiac precursor-like cells from human menstrual blood-derived mesenchymal cells. Stem Cells, 26, 1965-1704.

 

Hou, G.Q., Chen, S.S., Lee, P.L. (2006) Pathogens in maternal blood and fetal cord blood using Q-PCR assay. Taiwanese J Obstet Gynecol, 45, 114-119.

 

Hovatta, O., Mikkola, M., Gertow, K., Stromberg, A-M., Inzunza, J., Hreinsson, J., Rozell, B., Blennow, E., Andang, M. and Ahrlund-Richter, L. (2003) A culture system using human foreskin fibroblasts as feeder cells allows production of human embryonic stem cells. Human Reproduction, 18 (7), 1404-1409.

 

Imarai, M., Candia, E., Rodriguez-Tirado, C., Tognarelli, J., Pardo, M., Perez, T., Valdes, D., Reyes-Cerpa, S., Nelson, P., Acuna-Castillo, C. and Maisey, K. (2008) Regulatory T cells are locally induced during intravagainal infection of mice with Neisseria gonorrhoeae. Infection and Immunity, Dec., 5456-5465.

 

Kieusseian, A. and Cumano, A. (2008) Are hematopoietic stem cells generated in the placenta? Cell Stem Cell, 2, 197-198.

 

Kita, E., Matsuura, H. and Kashiba., S. (1981), A mouse model for the study of gonococcal genital infection. J Infect Dis, 143(1),  67-70.

 

Kjaergaard, N., Hein, M., Hyttel, L., Helmig, R.B., Schonheyder, H.D., Uldbjerg, N. and Madsen, H. (1999) Antibacterial properties of human amnion and chorion in vitro. Eur J Obstet & Gynecol and Reprod Biol, 94, 224-229.

 

Kobayashi, M., Yakuwa, T., Sasaki, K., Sato, K., Kikuchi, A., Kamo, I., Yokoyama, Y. and Sakuragawa, N. (2008) Multilineage potential of side population cells from human amnion mesenchymal layer. Cell Transplantation, 17, 291-301.

 

Kogler, G., Sensken, S., Airey, J.A., Trapp, T., Muschen, M., Feldhan, N., Liedtke, S., Sorg, R.., Fischer, J., Rosenbaum, C., Greschat, S., et al. (2004) A new human somatic stem cell from placental cord blood with intrinsic pluripotent differentiation potential. J Exp Med, 200(2), 123-135.

 

Kurtzberg, J., Laughlin, M., Graham, M., Smith, C., Olson, J., Halperin, E.C., Ciocci, G., Carrier, C., Stevens, C.E. and Rubinstein, P. (1997) Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients. NEJM, 335(3), 157-166.

 

La Scolea, L.J., Paroski, J.S., Burzynski, L., Faden, H.S. (1984) Chlamydia trachomatis infection in infants delivered by cesarean section. Clin Pediatr, 23(2), 118-20.

 

Lieberman. J.M. (2008) Neisseria gonorrhoeae. Long: Principles and Practice of Pediatric Infectious Diseases, 3rd ed., Elsevier, Chap. 126

 

Lyons, J.M., Ito, J.I. and Morre., S.A., (2004)Chlamydia trachomatis serovar E isolates from patients with different clinical manifestations have similar courses of infection in a murine model:  host factors as major determinants of C trachomatis mediated pathogenesis. J Clin Pathol, 47, 657-659.

 

Mardh, P.A., Helin, I., Bobeck, S., Laurin, J. and Nilsson, T. (1980) Colonization of pregnant and puerperal women and neonates with Chlamydia trachomatis. Br J Vener Dis, 56, 96-100.

 

Mardh, P.A., Johansson, P.J., Svenningsen, N. (1984) Intrauterine lung infection with Chlamydia trachomatis in a premature infant. Acta Paediatr Scand, 73, 569-572.

 

Matovina, M., Husnajak, K., Mulutin, N., Ciglar, S. and Grce, M., (2004) Possible role of bacterial and viral infections in miscarriages. Fertility and Sterility, 81(3), 662-669.

 

McGee, Z.A., Stephens, D.S., Hoffman, L.H., Schlech, W.F. and Horn, R.G., Mechanisms of mucosal invasion by pathogenic Neisseria. Rev Infect Dis, 5(4), 708-714.

 

McGee, Z.A., Gregg, C.R., Johnson, A.P., Kalter, S.S. and Taylor-Robinson, D. (1990) The evolutionary watershed of susceptibility to gonococcal infection. Microbial Pathogenesis, 9, 131-139.

 

Meng, X., Ichim, T.E., Zhong, J., Rogers, A., Yin, Z., Jackson, J., Wang, H., Ge, W., Bogin, V., Chan, K.W., Thebaud, B. and Riordan, N.H. (2007) Endometrial regenerative cells:  A novel stem cell population. J Transl Med, 5(57), 1-10.

 

Mlyncek, M., Pec, J., Belej, K. (1988) The effect of amniotic fluid on Neisseria gonorrhoeae. J Gynecol Obstet Biol Reprod, 17(3), 33307.

 

Neeper, I.D., Patton, D.L. and Kuo, C-C. (1990) Cinematographic observations of  growth cycles of Chlamydia trachomatis in primary cultures of human amniotic cells. Infection and Immunity, 58(7), 2042-2047.

 

Nowicki, S., Selvarangan, R. and Anderson, G. (1999) Experimental transmission of Neisseria gonorrhoeae from pregnant rat to fetus. Infection and Immunity, 67(9), 4974-4976.

 

Patel, A.N., Park, E., Kuzman, M., Benetti, F., Silva, F.J. and Allickson, J.G. (2008) Multipotent menstrual blood stromal stem cells: Isolation, characterization and differentiation. Cell Transplantation, 17, 303-311.

 

Pec, J., Jr., Moravik, P., Kliment, J., Fetisov, I. (1988) Isolation of Neisseria gonorrhoeae from urine obtained by suprapubic puncture of bladders of men with gonococcal urethritis. Genitourin Med, 64, 156-8.

 

Ramsey, K.H., DeWolfe, J.L. and Salyer, R.D. (2000) Disease outcome subsequent to primary and secondary urogenital infection with murine and human biovars of Chlamydia trachomatis. Infection and Immunity, 68(12), 7186-7189.

 

Rubinstein, P. (1993) Placental blood-derived hematopoietic stem cells for unrelated bone marrow reconstitution. J Hematotherapy, 2(2), 207-10.

 

Schwetz, B.A. (2001) Artificial skin grafts. JAMA, 285(13), 1696.

 

Seghatchian, M.J. (1999) What’s happening? Cord blood derived stem cells: current views. Transfusion Science, 20, 141-142.

 

Shurbaji, M.S., Dumler, J.S., Gage, W.R., Pettis, G.L., Gupta, P.K. and Kuhadja, F.P. (1990) Immunohistochemical detection of chlamydial antigens in association with cystitis.  AJCP, 90(1), 363-366.

 

Smith, L.G., Summers, P.R., Miles, R.W., Biswas, M.K., Pernoll, M.L. (1989) Gonococcal chorioamnionitis associated with sepsis: A case report. AmJ Obstet Gynecol, 160(3), 573-7.

 

Sollecito, D., Panero, A., Midulla, M., Colarizi, P., Roggini, M., Bucci, G. (1987) Prenatal Chlamydia trachomatis infection with postnatal respiratory disease in a preterm infant. Acta Paediatr Scand, 76, 532.

 

Song, W., Condron, S,. Mocca, B.T., Veit, S.J., Hill, D., Abbas, A., Jerse, A.E. (2008) Local and humoral immune responses against primary and repeat Neisseria gonorrhoeae genital tract infections of 17β-estradiol-treated mice. Vaccine, 26, 5741-5751.

 

Stokes, G.V., Isada, N.B. (1991) Albumin enhances Chlamydial infectivity on human placental cells. Microbios, 65(264-265), 179-86.

 

Swanson, J. (1973) Studies on gonococcus infection IV. Pili: Their role in attachment of gonococci to tissue culture cells. J Exp Med, 137, 571-589.

 

Talmi, Y.P, Finkelstein, Y. and Zohar, Y. Use of human amniotic membrane as a biologic dressing. (199) Eur J Plast Surg, 13, 160-162.

 

Thomas, G.B., Jones, J., Sbarra, A.J., Cetrulo, C., Reisner, D. (1990) Isolation of Chlamydia trachomatis from amniotic fluid. Obstet Gynecol, 76 (3), 519-20.

 

Thorp, J.M., Katz, V.L., Fowler, L.J., Kurtzman, J.T., Bowes, W.A. (1989) Fetal death from chlamydial infection across intact amniotic membranes. Am J Obstet Gynecol, 161(5), 1245-6.

 

Tuffrey, M., Falder, P., Gale, J., Taylor-Robinson, D. (1988) Failure of Chlamydia trachomatis to pass transplacentally to fetuses of TO mice infected during pregnancy. J Med Microbiol, 24, 1-5.

 

Vanrompay, D., Hoang, T.Q., DeVos, L., Verminnen, K., Harkinezhad, T., Chiers, K., Morre, S.A. and Cox, E. (2005) Specific-pathogen-free pigs as an animal model for studying Chlamydia trachomatis genital infection. Infection and Immunity, 73(12), 8317-8321.

 

Vile, Y., Carroll, S.G., Watts, P., Ward, M., Nicolaides, K.H. (1997) Chlamydia trachomatis infection in prelabour amniorrhexis. Br J Obstet Gynaecol, 104(9), 1091-3.

 

Weinberg, W., Smith, L.P., Karney, W.W. (1983) Chlamydia trachomatis: An uncommon cause of cystourethritis in female dependents of military personnel. Military Medicine, 148, 543-4.

 

Wilshaw, S-P., Kearney, J.N., Fisher, J. and Ingham, E. (2006) Production of an accellular amniotic membrane matrix for use in tissue engineering. Tissue Engineering, 12(8), 1217-2129.

 

Yvert, F., Frost, E., Walter, P., Gass, R. and Ivanoff, B. (1985) Prepartal infection of the placenta with Neisseria gonorrhoeae. Genitourin Med, 61, 103-5.

 

Zhang C., Zhu, D., Guo, X. (2002) A study on ways of intrauterine infection of Chlamydia trachomatis. Zhonghua Fu Chan Ke Za Zhi, 37(3), 149-51.