No fast start

A year af­ter lim­its lifted, process goes slowly to get stem-cell re­search mov­ing

Modern Healthcare - - The Week In Healthcare - Jes­sica Zig­mond

Progress to ad­vance U.S. stem-cell re­search has been slow but steady since Pres­i­dent Barack Obama re­voked a pol­icy that had lim­ited this area of sci­en­tific study for nearly eight years. This month marks the one-year an­niver­sary of Obama’s an­nounce­ment that over­turned the Au­gust 2001 or­der by Pres­i­dent Ge­orge W. Bush that lim­ited the amount of fed­eral fund­ing for stem-cell re­search.

Bush’s state­ment said fed­eral fund­ing could not be used for such re­search un­less cer­tain con­di­tions were met: the deriva­tion process—which starts with the de­struc­tion of an em­bryo—must have been ini­ti­ated be­fore Aug. 9, 2001; the stem cells must have been taken from an em­bryo that was cre­ated for re­pro­duc­tive pur­poses and no longer needed; and in­formed con­sent must have been ob­tained for the do­na­tion of an em­bryo that was ob­tained without fi­nan­cial in­duce­ments.

Stem cells, which are un­spe­cial­ized cells that have the ca­pa­bil­ity of re­new­ing them­selves through cell divi­sion—even af­ter long pe­ri­ods of in­ac­tiv­ity—can also give rise to spe­cial­ized cells for tis­sues or or­gans un­der cer­tain phys­i­o­log­i­cal or ex­per­i­men­tal con­di­tions, ac­cord­ing to the Na­tional In­sti­tutes of Health. Be­cause of their re­gen­er­a­tive abil­i­ties, th­ese cells could cre­ate the po­ten­tial for treat­ing con­di­tions such as di­a­betes and Parkin­son’s and heart dis­ease.

With his or­der last year, Obama opened the na­tion’s $29 bil­lion bud­get for stem-cell re­search (March 16, 2009, p. 6) and also lifted the lim­i­ta­tions that Chil­dren’s Hospi­tal Bos­ton physi­cian sci­en­tist Leonard Zon said have “greatly ham­pered” the abil­ity to con­duct re­search in this field.

Zon said that even though money is be­ing spent and sci­en­tists are able to do re­search, the process by which stem-cell lines are avail­able un­der NIH fund­ing has taken a lit­tle more time than peo­ple thought. “Af­ter the ban, there has been a lit­tle bit of lag time to get up to speed,” said Zon, di­rec­tor of Chil­dren’s stem-cell pro­gram.

That process be­gan with draft guide­lines for re­search in­volv­ing hu­man em­bry­onic stem cells, which the NIH re­leased in late April 2009. The NIH re­ceived 49,000 pub­lic com­ments from pa­tient ad­vo­cacy groups, scien- tists, sci­en­tific so­ci­eties, med­i­cal so­ci­eties, aca­demic in­sti­tu­tions, re­li­gious or­ga­ni­za­tions and pri­vate cit­i­zens be­fore the guide­lines be­came ef­fec­tive on July 7, 2009. In early De­cem­ber, the agency said it had ap­proved 13 hu­man em­bry­onic stem-cell lines for use in NIH-funded re­search.

A rep­re­sen­ta­tive for the NIH was un­avail- able for an in­ter­view, but a spokesman said in an e-mail that the fis­cal 2009 fig­ure for hu­man em­bry­onic stem-cell re­search was $143 mil­lion, which in­cludes $14 mil­lion from the Amer­i­can Re­cov­ery and Rein­vest­ment Act of 2009, also known as the stim­u­lus law. The fis­cal 2010 fund­ing amount is ex­pected to be $137 mil­lion, in­clud­ing $23 mil­lion from the stim­u­lus law.

In the last year, Zon has worked closely with col­league Ge­orge Da­ley and a team at Chil­dren’ Hospi­tal—which pro­duced 11 of those 13 lines the NIH ap­proved—to de­velop a new Web site that is in­tended to de­bunk some of the myths about stem-cell re­search and also ed­u­cate pa­tients.

“The prom­ises of stem-cell re­search are real, but we also want to be ac­cu­rate in what can be done and what can’t be done,” said Zon, who added that he re­ceives a call each week from some­one want­ing to travel out­side the United States for treat­ment. “There are com­pa­nies in China that will in­ject weird things into you with a prom­ise that they will cure di­a­betes,” said Zon, who ac­knowl­edged that a per­son with a se­ri­ous dis­ease “might be will­ing to try any­thing.”

Chil­dren’s Hospi­tal’s new Web site, stem­cellchil­dren­shos­pi­tal.org, is sched­uled to launch on April 26. Zon said the idea be­hind the Web site is to give peo­ple the tools to un­der­stand the re­search so that they can ed­u­cate oth­ers. “The big­gest mis­con­cep­tion has to do with em­bry­onic stem cells,” Zon said, adding that most peo­ple pic­ture a fe­tus when they think of stem cells. “When we’re mak­ing th­ese lines, there is no ner­vous sys­tem or tis­sue ex­cept a solid ball of cells.”

Don­ald Gib­bons is the chief com­mu­ni­ca­tions of­fi­cer at the Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Medicine, a grant­ing agency in Sacra­mento that was cre­ated af­ter Cal­i­for­nia vot­ers took the ini­tia­tive to ad­vance stem-cell re­search ef­forts in the ab­sence of fed­eral fund­ing.

In 2004, vot­ers passed a ref­er­en­dum that al­lowed for $3 bil­lion in bonds to fund stem-cell re­search for 10 years, ac­cord­ing to Gib­bons, who said the in­sti­tute has awarded $1 bil­lion of those funds to date, in­clud­ing $270 mil­lion that was used to build 12 stem­cell fa­cil­i­ties.

As Gib­bons ex­plained, there was much ex­cite­ment in the field when the seg­ment learned a year ago that it had a part­ner in the fed­eral gov­ern­ment. He also said he fears that the pub­lic might not un­der­stand how many dif­fer­ent types of stem cells there are, and how long it will take to move be­yond the clin­i­cal re­search phase to the ap­proval phase.

Ear­lier this month, the Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Medicine al­lo­cated $50 mil­lion for stem-cell ther­apy de­vel­op­ment. “This fund­ing will help speed the pace of mov­ing th­ese po­ten­tial ther­a­pies through clin­i­cal tri­als and, if those tri­als prove suc­cess­ful, into doc­tors’ offices,” the in­sti­tute said in a March 11 news release.

At 396-bed Chil­dren’s Hospi­tal, Zon said one area of stem-cell re­search that re­quires im­prove­ment is mak­ing or­gans from stem cells. “We’ve learned how to make the cells,” Zon said. “Now let’s learn how to make them use­ful.”

The NIH has ap­proved 13 new stem-cell lines for re­search.

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