Crohn’s disease is a chronic inflammatory condition that can cause severe abdominal pain, diarrhea, and weight loss. Current treatments are only partially effective, and there is a great need for more effective therapies. Even with advances in Crohn’s disease treatments, about 25% of Crohn’s patients still need major abdominal surgery within five years of receiving their diagnosis.
Researchers are looking for new ways to treat the symptoms of Crohn’s disease and to find possible cures for the inflammatory bowel disorder. The goals of treatment are to reduce symptoms caused by inflammation, limit any complications and get the disease under control to prevent permanent damage.
One promising approach is stem cell therapy. This therapy has the potential to provide lasting remission of symptoms and improve quality of life for Crohn’s patients. It is an exciting area of research that holds much promise for the future.
Clinical trials are underway to test the efficacy of stem cells in treating Crohn’s disease and other inflammatory disorders. The hope is that stem cells will help to repair and regenerate damaged tissue in the gastrointestinal tract.
A clinical trial, A Phase 2 Study of Allogeneic Mesenchymal Stromal Cells for Luminal Crohn’s Disease Refractory to Biologic Therapy, looked into the potential of using stem cells to treat patients with Crohn’s disease.
Results of the Study
The goal of the trial was to determine the potential clinical efficacy of stem cell therapy for Crohn’s disease. The researchers determined the clinical response by determining if Crohn’s Disease Activity Index (CDAI) scores decreased by at least 100 points. The researchers based the secondary outcomes of the treatment based on clinical remission, endoscopic improvement, assessment of quality of life, improved quality of life, and analysis of C-reactive protein.
The study included 16 patients who suffered from Crohn’s disease with an average CDAI of 371. Patients received a dose of two million mesenchymal stem cells intravenously four times. Each treatment was one week apart. The study took place over the course of 42 days. The results of the study were encouraging for patients with Crohn’s disease.
The number of patients saw improvements in their CADI scores. Some patients even went into clinical remission, in fact, eight patients were in clinical remission by day 42. Patient 13 had a huge improvement in CADI score. This patient started with a score of 327, and ended with a score of 50. On day 28, patient 13 even reached a CADI score of 0. Other patients experienced similar improvements in CADI scores. Patient 5 went from a CADI score of 325 to 44 at the end of the study, and patient 9 went from a CADI score of 256 to 81.
Only three out of the sixteen patients did not show any improvement in their CADI scores. Seven patients saw improvements through an endoscopy and CDEIS scores decreased from 21.5 to 11.
Quality of life improved for most patients that experienced a clinical response. These patients saw IBDQ scores that improved from 118 to 158 and the AQoL scores that improved from 80 to 63. For patients that went through clinical remission, IBDQ scores went from 125 to 163 and AQoL scores went from 82 to 60.
Most patients did not experience any adverse events from the treatment. One patient did have two dysplasia-associated lesions during the course of the study, but the researchers concluded that the stem cells did not likely cause this event. All patients experienced taste distortion which is common from the cryopreserving agent dimethylsulfoxide, but the distortion went away within 36 hours. Some other mild events were headaches, mild nausea, and other events that were related to pre-existing conditions.
The study showed that repeated infusions of stem cells were potentially beneficial for patients with Crohn’s disease. Patients who continue to suffer from relapses could simply go get an infusion of stem cells to relieve their symptoms and take their disease into remission.
Overall, the studies point to the potential of stem cell therapy. The results showed that 12 out of the 15 patients (80%) had a clinical response, 8 patients (53%) achieved clinical remission, and 7 patients (47%) had endoscopic improvement. In addition, the patients’ quality of life improved after treatment with allogeneic MSCs.
These findings suggest that allogeneic MSCs may be a promising new treatment for Crohn’s disease. These results provide hope for patients suffering from luminal CD who have few treatment options available. Further research is needed to confirm these findings and to determine the optimal dose and schedule of administration.
