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.
| 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 |
| 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 use of autologous or allogeneic adipose- or bone marrow-derived mesenchymal stem cells for equine musculoskeletal and nervous disease | Horse | Musculoskeletal diseases; Neurological diseases | Autologous or allogeneic equine adipose or bone marrow-derived mesenchymal stem cells | 06/2023-12/2033 | 06/2023-12/2033 | New York | ac2399@cornell.edu |
| The use of autologous or allogeneic adipose- or bone marrow-derived mesenchymal stem cells for equine keratitis | Horse | Immune-mediated keratitis | Autologous or allogeneic equine adipose- or bone marrow-derived mesenchymal stem cells | 06/2023-12/2033 | 06/2023-12/2033 | New York | kek248@cornell.edu |
| The use of autologous adipose- or bone marrow-derived mesenchymal stem cells for canine musculoskeletal and nervous disease | Dog | Musculoskeletal diseases; Neurologic diseases | Autologous canine adipose- or bone marrow-derived mesenchymal stem cells | 06/2023-12/2033 | 06/2023-12/2033 | New York | cwf37@cornell.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.