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96 Cards in this Set

  • Front
  • Back

Preclinical testing vs clnical trials

preclinical = no human testing. clinical = humans. clinical ends up in FDA approval but may still cause death in rare cases.

Clinical - P1

20-80 participants
up to several months
studies safety of Tx - "is it safe"
70% success rate

Clinical - P2

100-300 participants


up to 2 years


studies efficacy - "doess it work"


33% success rate

Clinical - P3

1000-3000 participants


1-4 years


safety, efficacy, dosing - studies rare side effects


25%-30% success rate



ends up with FDA approval

Clinical - P4

Thousands of participants.


1+ year (long-term)


Studies long-term effectiveness and cost effectiveness


70-90% success rate. may recall (like Vioxx)

Vioxx

(NSAIDs) - pain killers/antiinflammatory.


in P4 leads to heart attack, so there was a recall

stem cell research timeline

2010: phase 1 - people had cysts so they stopped.


2011 - pull the plug because of money

Nazi human experimentation

Joseph Mengele - did twin studies. were not treated humanely

Tuskegee Syphilis study

left black people with syphillis untreated - monitored. "free HC" - target poor uneducated black men. meant to be 6 months - ended up being 40 years. told them they had "bad blood"



Dr. Cutler

Guatemalan syphillis scandal

by US government. no consent - not informed. given syphillis. went there because it's illegal in the U.S. Descendants have it - started in 1940's. Found out about it in 2009 - appx. 5,500 people.



Dr. Cutler

three basicp rinciples of belmont report

A) respect for persons - informed consent without deception. protect people who can't decide.


B) beneficience - benefits fat outweigh the risk. "Do no harm"


C) Justice - we ALL share the burden of clinical trials - don't prey on poor, uneducated, prisoners, children (especially orphans)

3 concerns or risk factors associated with the use of human embryonic stem cells

1 - stem cells divide without limit - chance of tumor formation


2 - stem cells can go elsewhere - 70-80% go to correct area. hair tooth bone go in random areas.


3 - the cell is foreign and attacked by white blood cells. need to weaken the immune system first with immunosuppressant drugs (like with arthritis). stem cells are antigens. immunosuppressants may lead to illness

main controversy surrounding the use of embryonic stem cells

desstroys embryos

stem cells that are in clinical trials

heart disease


retinal disease


but in 2011 pulled the plug because of money

embryo categories

zygote = 1 cell


morula = many cells


blastocyst = embryo and fluid (at day 5) - when stem cells are harvseted


then gastrula

octamom

CSUF alum. had 8 eggs left - 6 were used, 2 split

ability for self-renewal means

can keep replicating and dividing if given food/water - but can form tumors

ability to differentiate means

can become different cell types

unique properties of stem cells

ability for self-renewal and ability to differentiate

pluripotent stem cells

can become any body cell - 220 cell types

multipotent stem cells

differentiate into some but not all body cells. blood stem cells don't give you all 220. can give you red blood cells, white blood cells and platelets

embryonic stem cells (ESC's)

donated from couples getting in-vitro fertilization (IVF)
take blastocyst (embryo @ day 5) when there's embryonic stem cells and fluid on other side


function - fom all body cells and tissues


pluripotent - more capacity - becomes all cells

why do people prefer Human Embryonic Stem Cells?

more capacity - 220 types of cells

how do researchers get embryonic stem cells

in-vitro fertilization. extract eggs from ovary surgically, fertilize them, grow to day 5, then use them

things to do with frozen embryos

keep frozen


thaw


donate to research


donate to another couple - obtained from consent, not abortion clinics.

Adult Stem Cells (ASC's)

originate from newborns and adults - cells beyond day 5


function - repair and maintenance of tissues


multipotent - differentiate only into some cells

therapeutic potential for adult stem cells

bone marrow transplant (inject stem cells 2 another person)


umbilical cord blood - get stem cells from umbilical cord and save them

induced pluripotent stem cells (iPSCs)

anthropogenic - made in lab


originate from any adult cell from body (skin). don't use embryos


function - repair of injured disease tissue


pluripotent

what are iPSCs
process of producing iPSCs
how iPSCs help address controversy around stem cells

inject skin cells with 6 genes (embryonic) - become embryonic.

testes

organs that produce sperm cells

epididymis

site of sperm development at maturity

Vasa deferentia (singular - vas deferens)

tubes lined with smooth muscle that cary sperm out of testes during ejaculation. site of vasectomy

seminal vesicle

structure adds fructose and prostaglandins to semen. fructose gives energy - prostaglandins induces contractions within female uterus to propel sperm up to the fallopian tubes

prostate gland

adds alkaline fluid to semen to protect sperm cells from the acidic environment of the female reproductive tract

bulbourethral gland

this structure secretes mucus to lubricate the urethra before ejaculation. produces "pre-ejaculatory" fluid

urethra

a duct that carries semen or urine out of the body

penis

male organ that deposits semen into the female vagina

scrotum

sac of skin and muscle that holds the testes external to the body where the temperature is cooler for increased sperm survival

bladder

stores urine

% of semen that is seminal

95% seminal fluid. 5% sperm cells. sperm comes from testes. seminal fluid comes from prostate gland, seminal vesicle and bulbourethral gland

review anatomy slide and identify parts

...

ovaries

organs that produce and store eggs (oocytes). females have 2 ovaries that alternate releasing a single egg once a month for one chance at fertilization

follicle

layer consisting of small cells; they surround, nourish, and protect a single egg

corpus luteum

structure that remains when the egg leaves the follicle during ovulation.

fimbriae

finger-like projections found at the end of the fallopian tube that help sweep the egg from the ovary into the fallopian tube during ovulation

fallopian tube

structure that the egg is released into during ovulation. also the site of fertilization and tubal ligation

endometrium

blood-rich tissue that lines the inside of the uterus. for pregnancy, embryo transplants into endometrium. thicken blood supply to embryo. when she's not pregnant, the endometrium thins and is shed during mensturation

cervix

the neck of the uterus - also the site that must dilate (widen) during prenancy

uterus

the womb. site of pregnancy

vagina

site of sperm deposit. aka birth canal

pathway of sperm from male reproductive organs to female reproductive organs

testes -> epididymis -> vas deferens -> urethra -> vagina -> cervix -> uterus -> fallopian tube

what is a vasectomy? how does it prevent pregnancy? why might it not be effective?

vasectomy = vas deferens are cut.


vas deferens can reconnect. "recanalization"

females can "have their tubes tied" in a procedure known as tubal ligation. How does this procedure prevent pregnancy? explain why 5 out of 1,000 women who have undergone tubal ligation may become pregnant after intercourse

tubes reconnect

ovarian cycle

day 7 - follicle and egg begin to separate


day 14 - "ovulation" - egg splits from follicle. follicle becomes corpus luteum.

menstural cycle

day 0 - 3/4/5 = mensturation (uterine endometrium gets released)


day 14 - ovary released from corpus luteum



endometrium progressively builds until day 28

purpose of ovarian cycle

release eggs and build up uterine lining

purpose of menstural cycle

clear out uterus lining.
essential for egg's release and preparation of uterus

estrogen levels during cycle

peak at end of week 2 (day 14), signaling the follicle to ovulate


drop significantly at day 1 (menses)

progesterone levels during cycle

peak at end of week 3 (day 21) and cause endometrium to thicken


trigger menses when drop at day 1

endometrium vein color

blue

endometrium spiral artery color

red

endometrium spiral gland

empty cavity

follicle development during cycle

follicle is tiny and gets increasingly larger. peaks at day 14, then releases the egg and becomes degenerating corpus luteum



follicle has tiny cells that protect and nourish the egg

do the ovary or endometrium secrete estrogen and progesterone?

the ovary does

hysterectomy

take out the uterus

what estrogen does during cycle

monthly egg development


triggers ovulation

what progesterone does during the cycle

progesterone (pro-"gestation")


targets endometrium (tissue inside uterus)


thickens endometrium (what embryo attaches to)

what does birth control do to cycle

prevents peak estrogen and peak progesterone to stabilize them out, then both drop to trigger mensturation



week 1-3 is active pills


week 4 = inactive pills/iron supplements

plan B - how does it prevent pregnancy? what guidelines for taking?

1) high amounts of progesterone and estrogen prevent ovulation/egg release


2) prevent fertilization - sperm can't fertilize


3) prevents implantation - embryo can't attach to endometrium/womb

age limit of birth control

age 39

organs involved in preseminal fluid production

1) prostate gland


2) seminal vesicle


3) bulbourethral gland

organ involved in sperm cell production

testes

semen ejaculation occurs in

urethra - preseminal fluid combine before it happens, then sperm and preseminal fluid combine during ejaculation.



250 million sperm - 250 individual sperm find egg to fertilize

what's lost during mensturation

the endometrium - blood-rich organ that has O2 and nutrients.

instructions for taking birth control

take same time daily
antibiotics lower efficacy

15 major events in pregnancy

WEEK 1


1) ovulation


2) fertilization and zygote formation


3) mechanisms against polyspermy


4) cleavage


5) implantation and hCG secretion


WEEK 2 & 3


6) primitive streak formation


7) development of extra-embryonic structures


8) gastrulation


WEEK 4


9) organogenesis


10) heart beats


11) limb buds appear


WEEK 5 & 6


12) SRY gene activation occurs


13) ossification of fetal skeleton


WEEK 7 & 8


14) apoptosis of limb buds


15) neurons generate action potentials

Ovulation

occurs in ovary/fallopian tube


mature egg is release and swept into fallopian tube via fimbriae. 24-hour period to become fertilized by sperm that traveled to the fallopian tube.


egg begins in follicle

Fertilization and zygote formation

occurs in fallopian tube


sperm burrows into egg. creats 46 chromosome zygote

mechanisms against polyspermy

occurs in fallopian tube


Polyspermy causes 3 copies of chromosome and failed pregnancy, causing a spotaneous abortion



Fast Block: fusion with egg creates electrical charge (positive) due to Na+. 10 seconds after fertilization.


Slow Block: 1 minute after - physical barrier of water

cleavage

occurs in fallopian tube


single cell -> multiple cells. zygote -> blastomeres, which split into more blastomeres > morula -> blastula (hollow ball) -> placentia

Implantation and hCG secretion
in uterus
implants into uterine lining from fallopian tube on to side of uterus.

Human Chorionic Gonadotropin hormone 1) communicates that you're pregnant 2) signals corpus luteum to stay and secrete hormones b/c pregnancy. makes endometrium stay thick by secreting progesterone.

This is what pregnancy test measures.

Morning sicknesss

keep blood clean for baby

primitive streak formation

forms into blastula -> bilateral symmetry

development of extra-embryonic structures

chorion, placenta, amnion and amniotic fluid, umbilical cord

chorion

membrane between fetus and mother - outermost membrane around embryo, developed by follicle cell. between egg and eggshell

placenta
connects fetus to uterine wall and allows nutrient uptake, waste elimination and gas exchange. attach to wall of uterus. umbilical cord arises from it.
placenta = endometrium (maternal cells) and chorion (embryo cells)

identify it by locating everything that's maternal cells and everything that's embryonic cells

amnion and amniotic fluid

amnion - @ first covers the embryo. fills with amniotic fluid (what fetus is suspended in - the stuff that leaks when you lose your water)



you can identify it bc everything around the fetus is amniotic fluid and around that is the amnion

pelvic brim

space between pelvis. allows the baby to be born. if baby's head is too large, have to have a caesarian section

thalitomide

supposed to alleviate morning sickness/sedative


but prevents apoptosis of limb buds, so fingers and toes don't separate. this made the FDA have clinical trials/rules

gastrulation

formation of three germ layers



endoderm (innermost layer) - creates digestive lining


mesoderm (middle layer) - bone tissue, cartilage and muscles (cardiac, skeletal muscle, smooth muscle)


ectoderm - skin and nervous system

organogenesis

major organs form

limb buds appear

projections from main body. no fingers/toes yet

SRY gene activation

Sex determining Region on Y


in males, Wolffian ducts become vas deferens


in females, mullerian ducts develop into fallopian tubes

ossification of fetal skeleton

intramembrenous ossification - axial skeleton (skull/ribs). collagen fibers become bone tissue



endochondral ossification - appendicular (arms/legs). cartilage becomes bone tissue



if mom doesn't have enough calcium, baby may die at birth or be born with major organ damage. mom's bones may break down to nurture baby.

apoptosis of limb buds

apoptosis is programmed cell death. extra flaps die and you have fingers/toes

neurons generate action potential

baby = now moving