Canadian regulators have approved the stem cell based drug Prochymal, manufactured by Orisis Therapeutics. The action of the regulators marks progress in the field of regenerative medicine. The company is based in Columbia, Maryland. Prochymal is suitable for the treatment of children with graft-versus-host disease. This condition is a complication of bone-marrow transplants, and is considered life-threatening.
Prochymal’s formulation includes Mesenchymal stem cells. They are extracted from bone-marrow, sourced from healthy adults, and further cultured. Up to ten thousand doses of Prochymal are produced from a single bone-marrow donation.
When donated bone-marrow does not match its recipient, the attack of a patient’s organs by immune cells can occur. This is known as graft-versus-host disease, and greatly affects the skin, liver and digestive tract of the patient afflicted with the condition. Current treatments of graft-versus-host disease include the use of steroids, whose action aims to control the immune attack. Most patients reject the treatment, and if no alternate action is taken, they can succumb to the disease.
Prochymal is the ray of hope that overcomes the graft-versus-host challenge. It has been found in a trial by Orisis, that the treatment of affected children with Prochymal, resulted in sixty percent of the recipients showing marked improvement after use. Researchers are positive that Prochymal will make a significant contribution to the execution of more successful bone-marrow transplants.
Prochymal has finally had its breakthrough, after years of failure during previous clinical trials. After many attempts, it was discovered that the drug was applicable to severe cases of graft-versus-host disease, and has now been dedicated to that niche. This is a positive message for all of us. Dedication and perseverance does produce desired results.
Prochymal’s Canadian approval is an important milestone for Orisis. The company intends to apply for a US Food and Drug Administration approval later this year, and is currently conducting further research in order to satisfy the requirements.
For further details on the study, please view the following link: