For Patients

Cell Therapy Introduction for Patients and Caregivers 

Background on Cells

Cells make up every living organism. Inside each cell are genetic instructions that determine its type and function. Every individual has stem cells. Stem cells are immature cells that can divide and mature into different types of specialized cells. This process is called differentiation. During this process specific genes in the cell’s DNA are turned on or off. This guides the cell to become of a particular type and function. 

The immune system is composed of specialized cells, some of which produce  antibodies.  Antibodies are special molecules produced by the “B lymphocytes of our immune system that specifically recognize and bind to foreign agents such as bacteria or viruses to help us fight infections and protect us from cancer cells. Sometimes however, antibodies can be misdirected against our own proteins and are associated with autoimmune diseases.

Autoimmune Diseases and Cells 

Autoimmune diseases can cause cell damage by mistaking healthy cells and tissue as foreign. The immune system attacks those cells or tissue and causes inflammation. This is often triggered by genetic predisposition and environmental factors but the causes are often unknown. Environmental factors may include infections, viruses, injury, and some chemicals.

What is Cell Therapy?

Cell therapy involves transferring specific types of cells into a person to treat disease. Many different cell types can be modified or engineered for use in therapy, depending on the condition being treated. Cell therapy using immune cells called T-lymphocytes are currently available to treat certain cancers and has shown promising results in clinical trials to treat some autoimmune diseases. 

Types of Cell Therapy

• Autologous Cell Therapy: Autologous cells are usually blood collected from the person’s own body. The cells are then modified outside of the body, and returned to the blood by infusion or injected into tissues. Using the body’s own cells decreases the risk of an allergic-type of response to reject them. 

  • CAR T Cell Therapy: Is a type of autologous cell therapy. T lymphocytes  are a type of immune blood cell. They can be engineered to express  a Chimeric Antigen Receptor (CAR) on their cell surface. This enables CAR-T cells to target and destroy specific cells that contribute to the autoimmune disease. 

• Allogeneic Cell Therapy: Allogeneic cells are collected and derived from someone other than the person being treated. The source of these cells can come from a variety of sources such as healthy donors' cord blood, or cell banks of undifferentiated cells. Allogeneic cells are often genetically engineered to improve their function.

  • NK Cell Therapy: Is a type of allogeneic cell therapy. NK cells are natural killer cells that target and eliminate autoreactive cells.  

How are cells collected from my body for autologous cell therapy?

Cells are collected by a process called apheresis. Blood is run through a machine that separates its components, and collects the desired blood cells, and returns the rest of the blood to the body.  A similar process known as  leukapheresis  harvests some of a person’s white blood cells (leukocytes). If the clinical trial you are interested in requires apheresis or leukapheresis the process will be discussed with you in detail. 

Pretreatment

Before receiving cell therapy a patient may need a conditioning regimen. This helps decrease the immune system’s activity and prepare the body to accept the cells after they are infused. This process usually involves low-dose chemotherapy. If the trial you are interested in requires chemotherapy, this process will be explained to you in detail. 

How are the modified cells administered to the body?

Once the modified cells are ready, they are introduced into the body by an infusion. Infusions can be administered intravenously (with an IV) or may require a peripherally inserted central catheter (PICC) line placement. PICC lines can be placed in an outpatient setting. If the trial you are interested in requires a PICC line, your provider will discuss the procedure in detail with you. Some cells may need to be injected directly into tissues.

Lifestyle Restrictions

Some cell therapy treatments require lifestyle restrictions to ensure safety of the patient and monitoring for possible adverse reactions. These usually include not driving for a certain amount of time and staying within a specified distance of the medical facility for a period of time immediately after cell infusion. 

Lifestyle restrictions specific to the trial you are interested in will be discussed with your research care team. Some trials may help decrease the burden of these restrictions. Your research care team will share these details with you. 

Who is part of my research care team?

As part of a clinical trial you will work with a variety of individuals that work together to provide care. This team includes, but is not limited to, your physician who is an expert in your autoimmune disease, a cell therapy physician, a cell therapy research nurse, and a research coordinator.  

Considering a clinical trial that uses cell therapy? 

Below are some suggested questions that can help you understand what the trial requires to help you make a decision about what treatment option works best for you.

1. Does this trial use my cells (autologous) or use donor cells (allogenic)?

2. Does this trial require chemotherapy treatment? If so, what does this process include?

3. Does this trial require a PICC line placement?

4. What are the lifestyle restrictions for this trial? Does the trial provide assistance with these restrictions?