MESENCHYMAL STROMAL CELLS
Background and Date of Approval
Mesenchymal stromal cells received approval from the U.S. Food and Drug Administration (FDA) on 20th May 2014 for the management of moderate to severe ulcerative colitis, Crohn's disease, and chronic pouchitis in adults.
Uses
It is used as a second line of treatment option for adults dealing with moderate to severe cases of ulcerative colitis (inflammation of the large bowel), Crohn's disease (inflammation affecting the digestive system), and chronic pouchitis (inflammation of the lining of a pouch created during surgery to treat ulcerative colitis) to help alleviate the signs and symptoms of these conditions.
How is it administered?
It is available as a 200MIU injection. It is given only in a hospital setup by a healthcare provider. It is infused directly into your veins by your physician. Your physician will decide the dosage and frequency of this injection based on the severity of your disease and other factors.
Side Effects
Mesenchymal stromal cells can cause some side effects like any other drug. The most common side effects are headache, joint pain, and common cold. Some of the serious side effects are allergic reactions (wheezing or difficulty breathing, hives, itching of the skin, swelling, feeling sick, pain at the infusion site, redness of skin), serious infections (chills, shivering, high fever, or rash), progressive multifocal leukoencephalopathy-PML (a rare fatal opportunistic infection of the central nervous system) and severe liver injury.
Warnings
Do not take this medication if you are under 18 or have allergies to Mesenchymal stromal cells or its components. Additionally, it is essential to avoid this medication if you have an active severe infection, such as tuberculosis (TB), blood poisoning, severe diarrhea and vomiting (gastroenteritis), or a nervous system infection. Another critical point is that you should not take this medication with other biological medicines that suppress your immune system such as natalizumab (a medication used for multiple sclerosis) or rituximab (a medication used for certain types of cancer and rheumatoid arthritis). Seek medical attention immediately if you ever experience symptoms suggestive of progressive multifocal leukoencephalopathy (PML), such as blurred vision, loss of vision, double vision, speech difficulties, weakness in an arm or leg, changes in your gait or balance, persistent numbness, decreased sensation, or memory issues, during the treatment with Mesenchymal stromal cells.
Precautions
It is essential to inform your doctor if you are pregnant, breastfeeding, or intending to get vaccinated. If you are of childbearing age, use reliable contraception during the treatment and, for four and half months following the last infusion.
Word of Advice
Mesenchymal stromal cells injection is for in-hospital use only and must be administered by a healthcare provider. Safety and effectiveness in elderly patients are comparable to younger adults; however, elderly patients require close monitoring. Inform your healthcare provider immediately if you experience symptoms suggestive of progressive multifocal leukoencephalopathy (PML), including blurred vision, loss of vision, double vision, speech difficulties, weakness in an arm or leg, changes in gait or balance, persistent numbness, decreased sensation, or memory issues. Mesenchymal stromal cells may require up to 14 weeks to demonstrate full effect in some patients with very active Crohn's disease. Inform your doctor if you do not notice improvement in your condition. Adhere to your scheduled doses throughout treatment. Maintain a Mediterranean diet comprising whole grains, vegetables, fruits, healthy fats, lean meats, fish, beans, and eggs to support immunity. Avoid smoking and alcohol consumption to support a healthier lifestyle.
References
Takeda Pharma A/S, Electronic medicines compendium (emc), [Revised on Apirl 2022] [Accessed on 22nd Sep 2023], https://www.medicines.org.uk/emc/product/5442/pil Takeda Pharmaceuticals America, Inc, US Food and Drug Administration (FDA), [Issued on May 2014] [Accessed on 22nd Sep 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf Goodman and Gilmanâs The Pharmacological Basis of Therapeutics, Pharmacology of Inflammatory Bowel Disease, 13th Edition, 2018, 950-951.
Frequently Asked Questions
Is Mesenchymal stromal cells injection indicated for children?
No, Mesenchymal stromal cells injection should not be administered to children and adolescents under 18.
How long should I take the Mesenchymal stromal cells injection?
If the Mesenchymal stromal cells injection works well for you, you can expect to follow a planned treatment regimen for approximately one year. Following this initial period, your doctor will evaluate your progress to determine if the treatment is still providing benefits. If it is, you have to continue with the treatment. To ensure that this medicine remains the right choice for you, schedule a review for every 12 months.
What precautions should I take during the treatment with Mesenchymal stromal cells injection?
Mesenchymal stromal cells injection can make you immunocompromised and prone to infections. Hence, to protect yourself, avoid contact with sick people and wash your hands frequently. Inform your doctor right away if you get fever, cold, cough, flu-like symptoms, unusual tiredness or weakness.
What are the most common side effects of Mesenchymal stromal cells injection?
The most common side effects of Mesenchymal stromal cells injection are common cold, headache, and joint pain.
Can I receive Mesenchymal stromal cells injections if I am taking other medications?
Inform your doctor about any prescribed medications, over-the-counter medicines, nutritional or vitamin supplements, and herbal products you take or have taken before the treatment. Tell your healthcare provider if you take or have recently taken any other immunosuppressive medications such as natalizumab, rituximab, corticosteroids or chemotherapy medications.