S. 288Senate117th Congress (2021-2023)In Committee

TRANSPLANT Act of 2021

Sponsored by Jack ReedSen. Jack Reed (D-RI)
Introduced February 8, 2021

AI-Generated Summary

Updated February 7, 2026 at 10:27 PM UTC

The TRANSPLANT Act of 2021 reauthorizes the Stem Cell Therapeutic and Research Act of 2005, providing new funding for the C.W. Bill Young Cell Transplantation Program and cord‑blood inventory, and adds measures to strengthen stem‑cell and regenerative‑medicine research and its workforce. It requires the Health Secretary to hold advisory council meetings at least twice a year and to conduct a scientific review of adult stem‑cell therapies every two years. The bill also directs the NIH to coordinate regenerative‑medicine efforts and orders a GAO report on the specialized workforce needed for these therapies.

Key Provisions

  • Secretary must convene the Advisory Council at least twice each calendar year
  • Funding authorized: $31 million per year FY2022‑2026 for the Cell Transplantation Program and $23 million per year FY2022‑2026 for cord‑blood inventory
  • Adds a mandatory review of the state of science on adult stem‑cell therapies every two years, with recommendations due by June 30 2025
  • NIH Director tasked to consult with relevant institutes and FDA to advance regenerative medicine using adult stem cells
  • GAO required to submit a report within two years assessing the workforce and training needs for stem‑cell and regenerative‑medicine fields

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S575)

February 8, 2021

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SenateIntro Referral

Introduced in Senate

February 8, 2021

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S575)

February 8, 2021

Floor Debate

3 members

What members said about S. 288 on the floor

3 Democrats
Mazie K. Hirono
Sen. Mazie K. HironoD-HI · Feb 8, 2021

Mr. President, I rise today to introduce the Safeguarding Against Fraud, Exploitation, Threats, Extremism and Consumer Harms Act, also known as the SAFE TECH Act. I thank my colleagues, Senator…

Dianne Feinstein
Sen. Dianne FeinsteinD-CA · Feb 8, 2021

Mr. President, I am pleased to introduce the ``Driftnet Modernization and Bycatch Reduction Act.'' I thank Senator Capito for her cosponsorship as well as continued partnership on this important…

Jack Reed
Sen. Jack ReedD-RI · Feb 8, 2021

Mr. President, today I am pleased to introduce the Timely Reauthorization of Necessary Stem Cell Programs Lends Access to Needed Therapies (TRANSPLANT) Act of 2021 with Senators Richard Burr, Tina…

Bill Text

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Introduced in SenateIssued February 8, 2021

II

117th CONGRESS

1st Session

S. 288

IN THE SENATE OF THE UNITED STATES

February 8, 2021

Mr. Reed (for himself, Mr. Burr, Ms. Smith, and Mr. Scott of South Carolina) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.

1.

Short title

This Act may be cited as the Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021 or the TRANSPLANT Act of 2021.

2.

Reauthorization of the C.W. Bill Young Cell Transplantation Program

(a)

Advisory council meetings

Subsection (a) of section 379 of the Public Health Service Act (42 U.S.C. 274k) is amended by adding at the end the following new paragraph:

(7)

The Secretary shall convene the Advisory Council at least 2 times each calendar year.

.

(b)

Increasing collection

(1)

Technical clarification

Effective as if included in the enactment of Public Law 114–104 (the Stem Cell Therapeutic and Research Reauthorization Act of 2015), the amendment to section 379(d)(2)(B) of the Public Health Service Act (42 U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of Public Law 114–104 is amended by inserting goal of increasing collections of high quality before cord blood units,.

(2)

Eliminating deadwood

Subparagraph (B) of section 379(d)(2) of the Public Health Service Act (42 U.S.C. 274k(d)(2)) is amended by striking the second and third sentences in such subparagraph.

(c)

Periodic review of state of science

Section 379 of the Public Health Service Act (42 U.S.C. 274k) is amended by adding at the end the following new subsection:

(o)

Periodic review of state of science

(1)

Review

Not less frequently than every 2 years, the Secretary, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the Administrator of the Health Resources and Services Administration, the Advisory Council, and other stakeholders, where appropriate given relevant expertise, shall conduct a review of the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the Program.

(2)

Recommendations

Not later than June 30, 2025, the Secretary shall—

(A)

complete the second review required by paragraph (1); and

(B)

informed by such review, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives recommendations on the appropriateness of the inclusion of new types of therapies in the Program.

.

(d)

Authorization of appropriations

Section 379B of the Public Health Service Act (42 U.S.C. 274m) is amended by striking $33,000,000 for fiscal year 2015 and $30,000,000 for each of fiscal years 2016 through 2020 and inserting $31,000,000 for each of fiscal years 2022 through 2026.

3.

Cord blood inventory

Subsection (g) of section 2 of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended to read as follows:

(g)

Authorization of appropriations

To carry out this section, there is authorized to be appropriated $23,000,000 for each of fiscal years 2022 through 2026.

.

4.

Advancing the field of regenerative medicine

Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by adding at the end the following:

(o)

Regenerative Medicine

The Director of NIH shall, as appropriate, continue to consult with the directors of relevant institutes and centers of the National Institutes of Health, other relevant experts from such institutes and centers, and relevant experts within the Food and Drug Administration, to further the field of regenerative medicine using adult stem cells, including autologous stem cells, therapeutic tissue engineering products, human cell and tissue products, human gene therapies, and genetically modified cells.

.

5.

GAO report on regenerative medicine workforce

Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that assesses a specialized health care workforce in the field of regenerative medicine. The report shall include—

(1)

an overview of the current employment levels, in both commercial and academic settings, for—

(A)

positions necessary for the collection and transplantation of stem cell therapeutics, including bone marrow and cord blood; and

(B)

positions in the field of regenerative medicine using adult stem cells and related to product development;

(2)

the identification of gaps, if any, in the projected workforce capacity for—

(A)

positions described in paragraph (1)(A); and

(B)

the field of regenerative medicine using adult stem cells, including workforce gaps related to the development of new cellular therapies using adult stem cells;

(3)

an overview of the availability of training programs related to the development, refinement, and utilization of adult stem cells, including training on good manufacturing practices for such activities, and the performance of such programs; and

(4)

recommendations, if any, for improving the workforce capacity related to—

(A)

the positions described in paragraph (1)(A); or

(B)

the field of regenerative medicine using adult stem cells.