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BP CC 001 is an investigational cell therapy. It is made from mesenchymal stromal cells obtained from umbilical cord tissue, referred to as UC-MSC. The substance is classified in the registry as a structurally diverse substance of the cell therapy type.[1] It is supplied by BIONCART GMBH and has no marketing authorisation in the product records, meaning it is still being investigated and is not an approved medicine.[1]
The product is prepared as a suspension containing 10 x 10⁶ UC-MSC in 1 ml of cell culture suspension. In the trial, this suspension is applied to a collagen support structure called Chondro-Gide®.[1]
Mesenchymal stromal cells from umbilical cord tissue are a type of cell that can support tissue repair. In cartilage damage, the idea behind a cell therapy such as BP CC 001 is that the cells may help the body rebuild or protect cartilage tissue in the knee joint. The registry data describe BP CC 001 as a cell therapy, but the exact mechanism by which the cells act in the knee is not described in the available trial record.[1]
BP CC 001 is given by intra-articular use, which means it is injected directly into the knee joint. The pharmaceutical form is a suspension. In the trial, the suspension is first applied to a collagen support structure, Chondro-Gide®, before being placed in the knee.[1]
One clinical trial of BP CC 001 is listed in the EU Clinical Trials Information System. It is a Phase 1/2 study, which means it combines an early phase that looks mainly at safety with a later phase that begins to look at whether the treatment works.[1]
The trial is currently authorised and plans to enrol 55 participants with cartilage defects of the knee joint. The main outcome measure is the proportion of patients who experience a serious adverse event within 24 months after surgery. This means the study is primarily designed to find out whether the treatment is safe.[1]
The study is interventional, meaning participants receive the investigational product as part of the research. The trial record does not provide further details on additional outcome measures or on the specific characteristics of participants who may be eligible.[1]
The available trial record does not include a list of known side effects for BP CC 001. The main purpose of the ongoing Phase 1/2 trial is to assess safety, including the proportion of patients with a serious adverse event within 24 months after surgery.[1]
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