Pemicu 3: 12 Patients Sickened by Contaminated Stem Cells

At least a dozen patients undergoing stem cell therapy developed bacterial infections after being
injected with unapproved stem cell products, according to the Food and Drug Administration.
Most of the patients were being treated for chronic back and joint pain.

All 12 patients were hospitalized, but there were no deaths. Seven of the infections were in
Texas, four in Florida and one was in Arizona. CDC investigators found E. coli bacteria in
unopened vials at two of the stem cell clinics where the patients were treated.

All of the patients received stem cells derived from umbilical cords that were initially processed
by Genetech, a San Diego stem cell manufacturer. The stem cells were recalled in October and
the FDA sent a warning letter to Genetech last month saying its donor selection, manufacturing
and safety standards were deficient.

Gottlieb has previously warned of “unscrupulous actors” in the stem cell industry that deceive
patients with “dangerously dubious products.” Critics have complained the agency's "go slow"
approach to regnerative medicine has delayed the development of promising new treatments
for autoimmune diseases, cancer, diabetes, neuropathy, back pain and other illnesses.

Diskusikan:

1. Apa saja hal-hal yang dapat mengkontaminasi kultur sel? Dapatkah kalian menjelaskan
efek dari kontaminasi terhadap kultur sel yang dilakukan?
2. Apa pengaruh dari kontaminasi E. coli pada pasien yang menerima terapi stem cell
tersebut? Mengapa stem cell yang diberikan sebagai terapi pada 12 pasien tersebut bisa
terkontaminasi E. coli? Jelaskan yang bisa kalian rekomendasikan untuk menghindari
terjadinya kontaminasi tersebut bahkan kontaminasi lainnya?
3. Dalam perkembangannya, teknik in vitro pada kultur sel sangat memungkinkan
terjadinya penyimpangan genetik. Mengapa hal ini bisa terjadi? Bagaimana cara
mencegahnya?
4. Untuk melakukan kultur sel, terdapat istilah freezing (Cryoperservation) dan thawing.
Bagaimana hal tersebut dapat dilakukan? Bagaimana pengaruhnya pada sel?
5. Dijelaskan bahwa Stem cells sebagai promising new treatments for autoimmune
diseases, cancer, diabetes, neuropathy, back pain and other illnesses. Jelaskan mengapa
stem cells dapat digunakan untuk penyembuhan penyakit diatas? Bagaimana hal
tersebut dilakukan?
6. Bagaimana anda mendesain fasilitas yang diperlukan untuk menunjang keberhasilan
proses kultur stem cell secara in vitro?