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Tolerogenic Fibroblasts · 1 trial · 2 indications
Monitor subjects for possible treatment-related acute immune symptoms or vascular occlusion symptoms during the administration of the allogeneic tolerogenic fibroblasts via intravenous infusion.
Complete Blood Count used to monitor inflammation markers included white blood cell (WBC), neutrophil (N), lymphocyte (L), neutrophil-lymphocyte ratio (NLR), mean platelet volume (MPV), and platelet-lymphocyte ratio. This safety test is to monitor subjects for inflammation during the course of the study, relating to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion
This test will measure the amount of certain substances in serum samples, including electrolytes (such as sodium, potassium, and chloride), fats, proteins, glucose (sugar), and enzymes. Blood chemistry tests give essential information about how well a person's kidneys, liver, and other organs are working. An abnormal amount of a substance in the blood can be a sign of disease or a side effect of treatment. Blood chemistry tests help diagnose and monitor many conditions before, during, and after treatment. Also called blood chemistry study.
A 12-lead electrocardiogram will be used to monitor the baseline cardiovascular health of the participants and continue to monitor their cardiovascular health during the course of the study measuring heart rate, blood pressure, ventricular rate, PR interval, RP interval, QRS interval, and GT interval. This safety test is to monitor the subjects for cardiac events related to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion
| Arm | Type | Description |
|---|---|---|
| tolerogenic fibroblasts administered via intravenous infusion | EXPERIMENTAL | A single dose of 100 million tolerogenic fibroblasts administered via intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| Tolerogenic Fibroblasts | BIOLOGICAL | administrating single dose of 100 million tolerogenic fibroblasts via intravenous infusion |
Inclusion Criteria: 1. Patients willing to sign an informed consent and capable of understanding the features of this clinical trial. 2. Willing to keep a weekly diary and undergo observation for four months 3. Non-pregnant patients 18-55 years of age with MS according to the revised McDonald crite...
Tolerogenic Fibroblasts is an investigational cell therapy being studied for the treatment of relapsing-remitting multiple sclerosis. It is currently in early Phase 1 clinical development, with a completed feasibility study in patients with refractory multiple sclerosis. The therapy is not yet approved and remains under clinical investigation.
Tolerogenic Fibroblasts is being developed by FibroBiologics, Inc., a company traded on the stock market under the ticker symbol FBLG. The company is conducting clinical research on this investigational therapy for multiple sclerosis.
Tolerogenic Fibroblasts is in early Phase 1 clinical development. A feasibility study with the therapy has been completed, but it remains investigational and has not received regulatory approval. The therapy is still in the early stages of clinical testing.
Tolerogenic Fibroblasts has one completed clinical trial, NCT05080270, titled 'Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis.' This early Phase 1 study enrolled 5 participants with relapsing-remitting multiple sclerosis and was conducted in Mexico.
Tolerogenic Fibroblasts is not FDA approved. It is an investigational therapy currently in early Phase 1 clinical development for relapsing-remitting multiple sclerosis. The therapy has completed a feasibility study but remains under clinical investigation and has not been approved for commercial use.