Clinical trials

Mesenchymal stromal cells (MSCs) are adult stem cells that have immunomodulatory, anti-inflammatory, and regenerative properties. The underlying mechanisms of MSCs differ depending on the disease treated, and more research is needed to develop our understanding on how MSCs can treat chronic illnesses. MSCs can be sourced from a variety of tissues, including bone marrow, adipose tissue (fat), and umbilical cord.

Bone marrow-derived MSCs are considered by researchers to have an excellent safety profile, and multiple peer-reviewed studies have found them to be safe. See for example this publication or the publications found on the Order cells page.

Clinical trials are research studies performed on people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, such as a new drug, is safe and effective in people.

Autologous stem cell treatments use cells derived form the patient's own body. In practice, this often involves extracting MSCs from the fat tissue and injecting the patient with a concentrate including stem cells from the fat. This treatment option is widespread today since it is not classified as a medicinal product. This however also means that there is no control from medical authorities such as EMA and FDA.

Allogeneic stem cell treatments use the cells obtained from a donor. Cellcolabs' cells are harvested from the bone marrow of healthy donors 18-28 years old, and cultivated in our production facility at the Karolinska Institute Campus in Stockholm.

There are various advantages with allogeneic MSC treatments produced by companies that follow the EU or US regulations. The quality is strictly regulated and controlled, meaning that we can be certain that the patient receives the intended amount and potency of cells. There is data indicating that MSCs from younger people are more potent than from older ones, which is why Cellcolabs' donors are young and rigorously screened. One donor can provide enough cells to more than 100 patients, and the cells are cryopreserved and readily available "off-the-shelf", enabling a comfortable experience for the patient and fast turnaround times for the healthcare system.

MSC treatment may produce measurable results within 3-6 months following treatment. This is indicated by a marked reduction in levels of inflammation and changes in general vitality, among other parameters measured for each specific study. It is also common for patients to report improvements in their quality of life and decreased symptoms within the first few weeks following treatment. However, every patient is unique and may respond to treatment differently. Some patients may not respond to the treatment at all. The main rationale for the clinical trials sponsored by Cellcolabs is to better understand these aspects.

Informed consent is the process by which a potential study participant agrees to participate in a trial after being provided with information about the study and treatment. It includes an explanation of what’s involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment. Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the participant’s satisfaction before an informed consent form (ICF) is signed. Participants have the right to refuse participation or to withdraw their consent at any time during the study without penalty.

The clinical trial process is designed to determine if you are a candidate for stem cell treatment. This process looks different for each trial, but the general outline is that that you have an initial consultation with a medical professional, a pre-evaluation at a clinic close to home, and a screening at the on-site clinic before the treatment.