This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Mesenchymal stromal cells were first approved for medical use on 20th May 2014 by U.S. Food and Drug Administration (FDA) for the management of moderate to severe cases of ulcerative colitis, Crohn's disease, and chronic pouchitis in adults.

Mechanism of Action of undefined

The primary mechanism of action of Mesenchymal stromal cells injection is to inhibit the activity of the protein on the surfaces of white blood cells, which is responsible for the inflammation associated with ulcerative colitis (colitis), Crohn's disease (Crohn's disease) and pouchitis (pouchitis)—this inhibition of the protein results in a decrease in the amount of inflammation.

Uses of undefined

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.

undefined Drug administaration and Dosage available

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.

Warnings, Precautions and Side Effects of undefined

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.

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.

Word Of Advice

Mesenchymal stromal cells injection is intended exclusively for in-hospital use and administered only by a healthcare provider. Regarding the safety and effectiveness of Mesenchymal stromal cells, there aren't any significant differences between elderly patients and younger adults. However, elderly patients should still undergo close monitoring. 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, it is crucial to inform your healthcare provider immediately. 

Mesenchymal stromal cells may take up to 14 weeks to show its full effect in some patients with very active crohn's disease. So, inform your doctor if you do not notice any improvement in your condition. Make sure to stick to your scheduled doses throughout your treatment. Take the Mediterranean diet of whole grains, vegetables, fruits, healthy fats, lean meats, fish, beans, and eggs to boost your immunity. To embrace a healthier lifestyle, avoid smoking and alcohol consumption.

Frequently Asked Question

References

  1. 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
  2. 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
  3. Goodman and Gilman’s The Pharmacological Basis of Therapeutics, Pharmacology of Inflammatory Bowel Disease, 13th Edition, 2018, 950-951.

Disclaimer

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.