Evidence map›Paper›PMID 34286927›Full record

ReviewClinical and translational science2021

The National Heart, Lung, and Blood Institute-funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy.

Ashraf El Fiky, Laarni Ibenana, Robert Anderson, Joshua M Hare, Aisha Khan, Adrian P Gee, Cliona Rooney, David H McKenna, Joseph Gold, Linda Kelley and 3 more

Open access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 3 countries.

Ashraf El FikyThe Emmes Company, LLC, Rockville, Maryland, USA.
Laarni IbenanaThe Emmes Company, LLC, Rockville, Maryland, USA.
Robert AndersonThe Emmes Company, LLC, Rockville, Maryland, USA.
Joshua M HareInterdisciplinary Stem Cell Institute, Miller School of Medicine, University of Miami, Miami, Florida, USA.
Aisha KhanInterdisciplinary Stem Cell Institute, Miller School of Medicine, University of Miami, Miami, Florida, USA.
Adrian P GeeCenter For Cell and Gene Therapy, Baylor College of Medicine, Houston, Texas, USA.
Cliona RooneyCenter For Cell and Gene Therapy, Baylor College of Medicine, Houston, Texas, USA.
David H McKennaMolecular and Cellular Therapeutics, University of Minnesota, Saint Paul, Minnesota, USA.
Joseph GoldCenter for Biomedicine and Genetics, City of Hope, Duarte, California, USA.
Linda KelleyMoffitt Cancer Center, Tampa, Florida, USA.
Martha S LundbergNational Heart, Lung, and Blood Institute, Bethesda, Maryland, USA.
Lisbeth A WelniakNational Heart, Lung, and Blood Institute, Bethesda, Maryland, USA.
Robert LindbladThe Emmes Company, LLC, Rockville, Maryland, USA.
Baylor College of Medicine · USEmmes (United States) · USHealth First · USNational Heart Lung and Blood Institute · USUniversity of Miami · USCity Of Hope National Medical Center · USMoffitt Cancer Center · USUniversity of Minnesota · US

Funding

NHLBI NIH HHS HHSN268201600011CNHLBI NIH HHS HHSN268201600012CNHLBI NIH HHS HHSN268201600013CNHLBI NIH HHS HHSN268201600014CNHLBI NIH HHS HHSN268201600020CNIH HHS HHSN268201600011INIH HHS HHSN268201600012INIH HHS HHSN268201600013INIH HHS HHSN268201600014INIH HHS HHSN268201600015INIH HHS HHSN268201600020C
6 · The paper itself

Abstract

The Production Assistance for Cellular Therapies (PACT) Program, is funded and supported by the US Department of Health and Human Services' National Institutes of Health (NIH) National Heart Lung and Blood Institute (NHLBI) to advance development of somatic cell and genetically modified cell therapeutics in the areas of heart, lung, and blood diseases. The program began in 2003, continued under two competitive renewals, and ended June 2021. PACT has supported cell therapy product manufacturing, investigational new drug enabling preclinical studies, and translational services, and has provided regulatory assistance for candidate cell therapy products that may aid in the repair and regeneration of damaged/diseased cells, tissues, and organs. PACT currently supports the development of novel cell therapies through five cell processing facilities. These facilities offer manufacturing processes, analytical development, technology transfer, process scale-up, and preclinical development expertise necessary to produce cell therapy products that are compliant with Good Laboratory Practices, current Good Manufacturing Practices, and current Good Tissue Practices regulations. The Emmes Company, LLC, serves as the Coordinating Center and assists with the management and coordination of PACT and its application submission and review process. This paper discusses the impact and accomplishments of the PACT program on the cell therapy field and its evolution over the duration of the program. It highlights the work that has been accomplished and provides a foundation to build future programs with similar goals to advance cellular therapeutics in a coordinated and centralized programmatic manner to support unmet medical needs within NHLBI purview.

Indexed as

Financing, GovernmentNational Heart, Lung, and Blood Institute (U.S.)Academies and InstitutesCell- and Tissue-Based TherapyGovernment RegulationUnited States

Identifiers

PMID34286927
PMCPMC8604220
OpenAlexW3184191165

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.