(Screen Capture/NIH)

(CNSNews.com) - A federal contract that the National Institutes of Health signed with the University of California at San Francisco requires UCSF to obtain body parts from unborn babies to make at least two types of “humanized mice,” according to “the statement of work” included in the contract solicitation published by NIH.

“The actual total amount of this contract, including all options, is $13,799,501 for a full performance period through December 5, 2020,” the NIH said in response to an inquiry from CNSNews.com. “We have obligated $9,554,796 to date.”

This NIH contract was originally signed with UCSF for a one-year period starting on Dec. 6, 2013 with the government retaining the option to renew the contract for up to six additional one-year periods running through Dec. 5, 2020. The next renewal deadline is Dec. 5 of this year.

The contract--using federal tax dollars--creates a demand for organs taken from late-term aborted babies and its fulfillment is dependent on the continued legality of late-term abortions.

Up to 24 Weeks in Gestational Age

A 2017 journal article said that the human fetal intestines used to create “SCID-hu gut mice” in research funded by this contract “were obtained from women with normal pregnancies before elective termination for nonmedical reasons.” The article said the intestines came from babies 18 to 24 weeks in gestational age.

The passage above from a Feb. 27, 2017 article in Pathogens describes how research conducted under the NIH contract with UCSF used intestines from babies aborted at 18 to 24 weeks in gestational age.

Similarly, a 2008 journal article describing how the UCSF professor who is the principle investigator for this contract engineers one version of the mouse required by the contract, said the professor used human fetal livers and thymuses taken from babies at 20-to-24 weeks gestational age.

The contract—which NIH calls “Humanized Mouse Models for HIV Therapeutics Development”--follows up on a similar contract (“Tissue Based Small Animal Model for HIV Drug Discovery”) that the NIH maintained with UCSF from Dec. 6, 2006 through Dec. 5, 2013.

The total value of that previous contract was $14,628,247, according to NIH.

While the NIH did respond to CNSNews.com’s inquiry about the monetary value of these two contracts, it did not specifically respond to sixteen questions about its current “Humanized Mouse Models for HIV Therapeutics Development” contract with UCSF. CNSNews.com sent these questions to the Department of Health and Human Services (of which NIH is a part) and UCSF. NIH and the University of California responded with statements.

(The sixteen questions CNSNews.com sent to HHS and UCSF and the full statements NIH and the University of California sent in response can be read by clicking here.)

The NIH's 'Statement of Work'

Some details about the actions required by this federal contract are described in the solicitation the NIH put out for the contract on Dec.31, 2012. Additionally, researchers at UCSF have published articles in medical journals that describe research funded by the contract.

The NIH solicitation includes a “statement of work” that says the contractor is specifically required to make two different types of “humanized” mice, using “human fetal thymus and liver” in constructing both.

The contractor, it says, is required to “[o]btain the necessary human fetal tissues for use under the contract” and to “ensure the quality” of that tissue.

The passage above from the “Statement of Work” attached to the NIH solicitation for its “Humanized Mouse Models for HIV Therapeutics Development” contract expressly informs the contractor that one function of the contract is to "[o]btain human fetal tissue.”

Similarly, the solicitation includes instructions for completing a “technical proposal” the contractor was required to submit. These instructions tell the contractor to ‘[i]dentify the source for fetal human tissues to be used in the model.”

The National Institutes of Health (NIH Photo)

“The current contract was awarded in 2006 to the University of California, San Francisco (contract No. HHSN266200700002C) and will expire in December, 2013,” says the statement of work. The expiring “contract No. HHSN266200700002C” referred to here is the “Tissue Based Small Animal Model for HIV Drug Discovery” contract, which NIH says had a total value of $14,628,247.

“The animal model being used is an immunodeficient mouse engrafted with human fetal thymus and liver (severe combined immunodeficiency (SCID)-hu Thy/Liv) and infected with well-characterized isolates of HIV-1,” the statement of work says of that then-expiring contract.

“This solicitation is seeking proposals for the SCID-hu Thy/Liv model and for a second humanized mouse model,” it continues. “The second mouse model will consist of immunodeficient mice engrafted with human fetal thymus and liver tissue and other cells and/or tissues, such that the model (or mice) has the following characteristics: can be infected by the systemic or mucosal routes, reconstitutes gut-associated and other lymphoid tissues, and develops viremia and disseminated infection in engrafted human tissue.”

“In summary” it says, “the present solicitation is for the SCID-hu Thy/Liv model and for an additional humanized mouse model.”

The passage above from the “Statement of Work” states that the “Humanized Mouse Models for HIV Therapeutics Development” contract will require the contractor to make two types of humanized mice, both using “human fetal thymus and liver.”

“The contractor shall provide both kinds of humanized mice,” the statement of work says.

It goes on to explain that the contractor will be required each month to provide one “cohort” of each of these two types of humanized mice—and that each of these “cohorts” must be made using tissue taken from a single fetal donor.

“The contractor,” the statement of work says about the first type of mouse, “shall provide up to 600 SCID-hu Thy/Liv and 60 unengrafted SCID mice per year for evaluations of single and combination therapies. One cohort of up to 50 SCID-hu Thy/Liv mice per month engrafted with tissue from a single donor, shall be available for evaluations.”

Of the second type of humanized mouse, the statement of work says: “The contractor shall provide up to 480 engrafted immunodeficient mice and 50 unengrafted mice per year for evaluations of single and combined therapies. One cohort of up to 40 mice per month, engrafted with tissue from a single donor, shall be available for evaluations.”

The passage above from the Statement of Work says the contractor shall make one “cohort” per month of each of the two types of humanized mice and that each of these cohorts (one numbering up to 50 mice and the other up to 40) will be made with human fetal thymus and liver tissue taken from “a single donor.”

The statement of work also says: “Specifically, the contractor shall: … Obtain the necessary human fetal tissues for use under the contract, consistently and reliably, and in accordance with all applicable Federal, State, and Local guidelines and regulations regarding the use of human fetal tissues.”

The solicitation’s instructions for completing the “technical proposal” say: “Identify the source for fetal human tissues to be used in the model, and document compliance with all applicable NIH policy and federal regulations (Public Health Service Act, 42 USC 289g-1 and 289g-2. … Provide documentation of successful acquisition of fetal tissue over the past year.”

It then says: “Document ability to produce engrafted mice in quantities required for this project.”

On Feb. 14, 2013, the NIH published an amendment to its solicitation for the “Humanized Mouse Models for HIV Therapeutics Development” contract. The purpose of the amendment, it said, was “to address several substantial questions that have been submitted by interested offerors.” The amendment then unambigiously reiterated that the contract would require the contractor to make two different types of humanized mice—and that both types needed to be made with human fetal livers and thymuses.

The text of the amendment posed this question: “Will a proposal be considered responsive if we propose to use a model in lieu of the required SCID-hu Thy/Liv model?”

The NIH answered as follows: “As specified in the Statement of Work (Attachment 3 of the solicitation), offerors must have in place two humanized mouse models, one being the SCID-hu Thy-Liv model ( failure to provide the SCID-hu Thy/Liv model would render your proposal unresponsive to the requirements of the solicitation ). [Underlining is in the original.]

“The second humanized mouse model,” the amendment continued, “must consist of immunodeficient mice engrafted with human fetal thymus and liver tissue and other cells and/or tissues, such that the model (or mice) has the following characteristics: can be infected by the systemic or mucosal routes, reconstitutes gut-associated and other lymphoid tissues, and develops viremia and disseminated infection in engrafted human tissue.”

The passage above from a Feb. 14, 2013 amendment to the NIH solicitation for the “Humanized Mouse Models for HIV Therapeutics Development” contract reiterated that the contractor would be expected to make two different types of mice, both using human fetal liver and thymus.

When the House Energy and Commerce Committee investigated fetal-tissue procurement in 2016, Harvard University responded to an inquiry from Rep. Jan Schakowsky (D.-Ill.) by providing the committee with a background paper in which it explained why mice with human immune systems could only be created with tissue taken from aborted babies.

“Mice that have human immune systems are an invaluable scientific resource, but these mice are engineered to this condition only by means of the use of human fetal material,” said the Harvard backgrounder.

“If human fetal tissue is needed, why can it not be obtained from miscarriages instead of abortion?” the backgrounder rhetorical asked.

“Here, timing is very important,” it said. “Almost all miscarriages happen at home or in locations in which fetal material is not recovered and, importantly, preserved in a usable state.”

The NIH's Humanized Rodent Workshop

In 2007, the NIH itself sponsored an event called “The New Humanized Rodent Model Workshop.” On Jan. 31, 2008, AIDS Research and Therapy published a summary of the presentations made at this NIH event. In one of these presentations, the UCSF professor who was then the principal investigator for the NIH’s “Tissue Based Small Animal Model for HIV Drug Discovery” contract (and is now the principal investigator for the ongoing “Humanized Mouse Models for HIV Therapeutics Development” contract) described the basic construction of the “SCID-hu Thy/Liv mouse model.”

(Screen Capture/NIH)

This model was required by both the current and previous NIH contract with UCSF.

A table in the summary indicated that this “humanized rodent” was made with “[h]uman fetal liver and thymus (20-24 g.w.).”

“This model…consists of SCID mice implanted with syngeneic pieces of human fetal liver tissues by surgical placement under their kidney capsules,” the summary said. “A single donor provides sufficient tissue to implant 50-60 mice.

“The mice are implanted at about 8 weeks of age, and by 18 weeks the implant grows into a tissue that resembles human fetal thymus with sufficient volume to infect by direct injection with HIV-1.

“This approach,” the summary said, “permits the generation of about 1,200 mice/year.”

The summary argued that a “major advantage” of making humanized mice this way was the large number of mice that could be made from a single “donor” baby.

“A major advantage of the SCID-hu model is that large cohorts of mice can be constructed from the same donor removing a potential confounding variable in comparative drug studies of the differential response of tissues from different donors,” it said.

“This also permits the production of mice at a low cost per mouse,” it said.

But there were drawbacks, too, the summary concluded: “Use of the SCID-hu Thy/Liv model is limited by the requirement for fetal tissue, the need for surgical construction of each mouse, the lack of immune responses generated by human T cells, and the limitation of HIV infection to the human thymic implant.”

On Jan. 12, 2016, Stem Cell Reports published an article describing research funded by the current NIH contract with UCSF. This article described a version of the humanized mouse that used fetal bone marrow as well as liver and thymus.

Co-authored by the same UCSF professor who had given the presentation at NIH’s 2007 humanized rodent workshop, the Stem Cell Reports article said this type of humanized mouse also used tissue taken from babies at 20 to 24 weeks in gestational age.

“Important from a medical standpoint,” this article said, “we show that transfers of human fetal liver (~E20-24 gestational weeks) into BLT (BM, liver, thymus) humanized mice readily gives rise to peritoneal B cells expressing a phenotype similar to B-1a cells that are derived from mouse fetal liver transplants.”

“Humanized BLT mice were generated as described by [the contract’s principal investigator],” said the article. “In brief, two 1-mm³ pieces of human fetal liver and one 1-mm³ piece of thymus (Thy/Liv) were implanted together under the kidney capsule of 10-week-old female NSG mice.

“Three weeks after the Thy/Liv implantation, NSG mice were irradiated (225 cGy) and injected 30 hr later with 2-10x10⁵ CD34+ autologous human fetal liver cells (20-24 gestational weeks) containing heterogenous populations of hematopoietic progenitors, including HSCs.”

On Feb. 27, 2017, this same UCSF professor published an article—along with other UCSF researchers--in Pathogens. This article described yet another form of humanized mouse created under the contract—the “SCID-hu gut mice.”

“Fetal gut tissues (18-24 g.w.) were obtained from women with normal pregnancies before elective termination for nonmedical reasons with informed consent according to local, state and federal regulations,” says the Pathogen article.

“Single intact segments of human fetal intestine (2-3 cm in length) were transplanted subcutaneously on the back of 6-8 week-old male C.B17 scid mice,” it said.

When CNSNews.com sent HHS and UCSF sixteen questions about the "Humanized Mouse Models for HIV Therapeutics Development" contract, it attached copies of the NIH's Dec. 31, 2012 solicitation for the contract, which included the Statement of Work. It also attached copies of the Harvard background paper on human fetal tissue research, the Jan. 31, 2008 article in AIDS Research and Therapy summarizing the NIH's 2007 New Humanized Rodent Model Workshop, and the Feb. 27, 2017 article in Pathogens describing the construction of "SCID-hu gut mice" using intestines taken from babies at 18 to 24 weeks gestational age who had been in "normal pregnancies" before they were subjected to "elective termination."

One of the sixteen questions about this contract CNSNews.com sent to HHS and UCSF was: “The UCSF professor who is the principal investigator for this contract said at the NIH’s ‘New Humanized Rodent Models 2007 Workshop’ that the SCID-hu Thy/Liv model was constructed using human fetal liver and thymus from babies that were 20 to 24 gestational weeks in age. The same principal investigator co-authored a 2017 article in Pathogens that said the SCID-hu gut mice used in research funded by this contract were constructed using ‘fetal gut tissues’ taken from babies in ‘normal pregnancies’ who were subjected to ‘elective termination for nonmedical reasons’ at 18 to 24 weeks gestational age. What is the youngest gestational age an unborn baby can be and still be able to donate the type of tissue needed to create the humanized mice required by this federal contract?”

Another question CNSNews.com asked HHS and UCSF was this: “Are there any methods of abortion that cannot be used to terminate an unborn baby whose tissue is going to be used to create the humanized mice required by this contract because that method of abortion would cause the tissue to be damaged or spoiled in a way that would make it unsuitable for creating these humanized mice?”

Another was this: “If it were made illegal in the United States to abort an unborn child after that child has a detectable heartbeat would this federal contractor still be able to get the tissue it needs from aborted babies to construct the humanized mice required by this contract?”

NIH and the University of California responded with statements.

“NIH takes very seriously all ethical concerns surrounding fetal tissue research, and has a robust policy framework in place to ensure this research continues responsibly with the ultimate goal of improving health,” NIH said.

“As you may be aware, HHS is currently reviewing all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations,” it said.

“Regarding NIH-funded and conducted research, NIH is a biomedical research agency and conducts and funds research to enhance health, lengthen life, and reduce illness and disability,” it said. “NIH does not regulate and is not involved with medical services for abortions.

“In connection with some research projects, NIH-funded researchers obtain human fetal tissue for biomedical research under conditions governed by law, specifically sections 498A and 498B of the PHS Act, 42 U.S.C. §§ 298g-1 and 298g-2, through intermediaries such as university tissue banks, and clinics associated with universities and companies,” NIH said.

“Additionally,” it said, “NIH expects informed consent to have been obtained from the donor for any NIH-funded research using human fetal tissue as articulated in NOT-OD-16-033, which applies to all NIH-funded competing grant awards, non-competing grant awards, and R&D contracts. Legal requirements applicable to all NIH-conducted and funded research are outlined in the NIH Grants Policy Statement, which binds NIH grantees.

“Through research involving both humans and animals, scientists identify new ways to treat illnesses, extend life and improve health and well-being,” NIH said in its response to CNSNews.com. “When necessary, new hypotheses are tested in animals first in order to gather sufficient evidence of benefits and risks before considering possible use in humans.

“Importantly, mouse models with human immune cells derived from the transplantation of human fetal tissues have been used in various areas of research for some time, including to study HIV pathogenesis and test new drugs against HIV,” it said. “Research to develop new mouse models with human immune cells is an active area of research.

“NIH is currently funding research creating mouse models with components of the human immune system which do not use human fetal tissue as the source for the human immune cells,” it said. “For example, grant 5R01AI132963 was awarded to the University of Massachusetts Medical School, Worcester, to develop a humanized mouse model from human umbilical cord blood cells.

“Regarding the specific contract in question, this contract is for the production of specified numbers of humanized mice, which are necessary for certain biomedical research as noted in the Harvard background paper that you attached,” NIH said.

“This contract is not specific as to the source or quantity of donor tissue that is used in the production of these animal models,” the federal agency concluded.

The University of California responded with a statement saying it “conducts research using fetal tissue that is vital to finding treatments and cures.”

"The University of California conducts research using fetal tissue that is vital to finding treatments and cures for a wide variety of adult and childhood diseases and medical conditions,” the University of California said in its statement.

“This research is conducted in full compliance with federal and state law and is in keeping with the university’s education, research and public service missions,” said the statement.

“Since the 1930s, fetal tissue has been a critical component of biomedical science and breakthroughs that fundamentally changed the practice of medicine,” said the University of California. “Its importance to researchers today has not diminished, and it is still essential to ensuring that cells and tissues created from stem cells are correct. Fetal tissue is used for a broad range of research, from cell biology to the development of vaccines, including the polio vaccine that saved hundreds of thousands of lives and merited the 1954 Nobel Prize for Medicine."

On Aug. 7, CNSNews.com reported that the Food and Drug Administration had signed a $15,900 contract with Advanced Bioscience Resources to acquire “fresh” human fetal tissue to transplant into “humanized mice.” On Sept. 24, HHS issued a statement saying it had cancelled that contract and had “initiated a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.”

On July 11, the House Appropriations Committee approved a bill to fund HHS for fiscal 2019 that expressly prohibited HHS from funding research that uses fetal tissue taken from induced abortions. However, this appropriations bill was never brought up for a vote on the House floor. On Sept. 28, President Trump signed a “minibus” and continuing resolution that included funding for the Departments of Defense, Labor, HHS and Education for the entirety of fiscal 2019.

That spending law permits HHS to continue funding research using tissue taken from aborted babies.

The NIH estimates that it spent $103 million in fiscal 2018 on research that used human fetal tissue. It estimates that it will spend $95 million in the current fiscal year.