| Description |
This is a multi-centre, open label, dose escalation study to assess the safety, tolerability and efficacy of two infusions of CYP-001, in adults who have steroid-resistant GvHD.
This is a multi-centre, open label, dose escalation study to assess the safety, tolerability and efficacy of two infusions of CYP-001, in adults who have steroid-resistant GvHD.
Participants will receive standard of care treatment throughout the study, according to local procedures. The first eight participants will be enrolled in Cohort A and receive a CYP-001 dose of 1 million cells per kg, up to a maximum dose of 100 million cells, on Day 0 and Day 7. Subject to a safety review of data from Cohort A, an additional eight participants will be enrolled into Cohort B and receive a CYP-001 dose of 2 million cells/kg, up to a maximum dose of 200 million cells, on Day 0 and Day 7. The primary evaluation period concludes for each participant 100 days after the first dose of CYP-001. Participants will have study visits on Days 0, 3, 7, 14, 21, 28, 60 and 100. Subsequently, participants will enter a long term follow-up period, which concludes 2 years after the first dose of CYP-001. |
| Which differentiated cell type is used |
| Label |
mesenchymal stem cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000134 |
| Description |
A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Mesenchymal stem cells (MSCs) are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, and adipocytes. These cells originate mainly from the mesoderm of the embryo, which forms connective tissues, muscle, and the circulatory and urinary systems. However, in adults, MSCs are found in multiple tissues, including bone marrow, adipose tissue, the umbilical cord, and dental tissues.
The primary function of MSCs is to maintain and repair the tissues in which they are found. When damage occurs, the MSCs are able to migrate to the site of injury, where they aid in regenerating the damaged tissue by differentiating into the required cell type and by secreting growth factors that enhance tissue repair and reduce inflammation. Furthermore, MSCs can also act as immunomodulators, suppressing immune reactions and reducing inflammation, both locally and systemically.
Apart from their role in tissue maintenance and repair, MSCs are integral to the field of regenerative medicine and are being investigated for their therapeutic potential in various clinical settings. Owing to their multipotent nature, immunomodulatory activity, and the relative ease of isolation, these cells can be engineered and translated into therapies to treat a variety of diseases, including bone and cartilage defects, liver diseases, heart disorders, and autoimmune diseases, amongst others. They have also been used as vectors for anticancer agents and in cell and gene therapy applications.
(This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies only to some subtypes and species, and so should not be considered definitional.); Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2. |
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