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Clinical Field Studies for Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)

This page is a resource that provides animal owners, veterinarians, researchers, and the public with access to information on clinical field studies investigating the use of ACTPs in veterinary patients. A clinical field study is a research study in which animals are enrolled based on a study plan and are evaluated for effects of biomedical or health outcomes. Enrolled animals may be pets (dogs, cats, etc.) or production animals (cattle, pigs, etc.), depending on the study and product under investigation.

Participation in these studies is always voluntary. To find out more about any individual study, use the contact information provided for that study. Additional information regarding the study and/or the investigational product is considered confidential and may not be disseminated by FDA without express permission of the sponsor.

Sponsors must voluntarily consent to having CVM list their study information on this webpage; therefore, this may not provide a comprehensive list of active or ongoing clinical field studies for ACTPs. The list of studies is updated on this page quarterly.

The studies listed are investigational, and the ACTPs are not FDA approved. This means the safety and effectiveness of the ACTP is not yet determined.

For Developers: CVM Listing of Clinical Field Studies for Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs)

Study Name Species Condition Product Type Recruitment Period Study Period Country or State Contact Information
Stem Cell-based Treatment of Spina Bifida in English Bulldogs  Dog Spina bifida Allogeneic canine mesenchymal stem cells 07/2018-07/2024 07/2018-07/2024 California virc@ucdavis.edu
Adipose-Derived Mesenchymal Stem Cell Therapy for Cats with Chronic Gingivostomatitis Cat Gingivostomatitis Allogeneic feline mesenchymal stem cells 06/2020-06/2023 06/2020-06/2023 California barzi@ucdavis.edu
Efficacy of mesenchymal stem cell therapy for the management of cats with chronic enteropathy Cat Feline Chronic Enteropathy Allogeneic feline mesenchymal stem cells 04/2020-04/2023 04/2020-04/2023 California virc@ucdavis.edu
SSS 2023-001 Horse Septic synovial structures (joints, tendon sheaths, bursae) Allogeneic equine platelet rich plasma lysate 01/2023 – 12/2024 01/2023 – 12/2024 North Carolina, Virginia, California, Florida, Pennsylvania, New York lvschnab@ncsu.edu

The information on this webpage is listed at CVM’s discretion after securing from the sponsor consent to provide publicly their limited study information. At the time of listing, the information is intended for the sole purpose of disclosing legitimate clinical field studies conducted under a file with CVM in support of product development and approval. We are committed to ensuring that all information we publish reflects a level of quality corresponding to the nature and timeliness of the information; and, to disseminate the information as promptly as possible so that the public can benefit from FDA's mission to promote and protect human and animal health.


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