Last week two new papers came out echoing each other about the dangers of bogus “therapies” being offered by predatory stem cell clinics and the risks they pose to patients. The first was from the Pew Charitable Trusts entitled: ‘Harms Linked to Unapproved Stem Cell Interventions Highlight Need for Greater FDA Enforcement’ with a subtitle: … Continue reading Two voices, one message, watch out for predatory stem cell clinics
FDA
Medeor Therapeutics Completes Enrollment in CIRM-Funded Clinical Trial for Kidney Transplant Patients
A CIRM-funded clinical trial to help kidney transplant patients avoid the need for anti-rejection or immunosuppressive medications has completed enrollment and transplantation of all patients. Medeor Therapeutics’ MDR-101 Phase 3 multi-center clinical trial involved 30 patients; 20 of them were treated with MDR-101, and 10 control subjects were given standard care. CIRM awarded Medeor, based … Continue reading Medeor Therapeutics Completes Enrollment in CIRM-Funded Clinical Trial for Kidney Transplant Patients
Hitting our Goals: Accelerating to the finish line
Way, way back in 2015 – seems like a lifetime ago doesn’t it – the team at CIRM sat down and planned out our Big 6 goals for the next five years. The end result was a Strategic Plan that was bold, ambitious and set us on course to do great things or kill ourselves … Continue reading Hitting our Goals: Accelerating to the finish line
CIRM funded stem cell therapy could one day help stroke and dementia patients
Image Description: Microscope images showing brain tissue that has been damaged by white matter stroke (left) and then repaired by the new glial cell therapy (right). Myelin (seen in red), is a substance that protects the connections between neurons and is lost due to white matter stroke. As seen at right, the glial cell therapy … Continue reading CIRM funded stem cell therapy could one day help stroke and dementia patients
Regulated, Reputable and Reliable: FDA’s Taking Additional Steps to Advance Safe and Effective Regenerative Medicine Products
Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research In February 2020, CIRM presented a series of benchmarks for the responsible delivery of stem cell and regenerative medicine products. These benchmarks are outlined in the publication Regulated, reliable and reputable: Protect patients with uniform standards for stem cell treatments. In a nutshell, CIRM … Continue reading Regulated, Reputable and Reliable: FDA’s Taking Additional Steps to Advance Safe and Effective Regenerative Medicine Products
Hitting our goals: Making good progress
Way, way back in 2015 – seems like a lifetime ago doesn’t it – the team at CIRM sat down and planned out our Big 6 goals for the next five years. The end result was a Strategic Plan that was bold, ambitious and set us on course to do great things or kill ourselves … Continue reading Hitting our goals: Making good progress
Three UC’s Join Forces to Launch CRISPR Clinical Trial Targeting Sickle Cell Disease
Sickle shaped red blood cells The University of California, San Francisco (UCSF), in collaboration with UC Berkeley (UCB) and UC Los Angeles (UCLA), have been given permission by the US Food and Drug Administration (FDA) to launch a first-in-human clinical trial using CRISPR technology as a gene-editing technique to cure Sickle Cell Disease. This research … Continue reading Three UC’s Join Forces to Launch CRISPR Clinical Trial Targeting Sickle Cell Disease
Prime Time for Rocket
Rocket Pharmaceuticals, a company that specializes in developing genetic therapies for rare childhood disorders, just got a big boost from the European Medicines Agency (EMA). They were given a Priority Medicines (PRIME) designation for their therapy for Leukocyte Adhesion Deficiency-1 (LAD-1). CIRM is funding ($6.56 million) Rocket’s clinical trial for LAD-I, an immune disorder that … Continue reading Prime Time for Rocket
Going the extra mile to save a patient’s life
You can tell an awful lot about a company by the people it hires and the ability it gives them to do their job in an ethical, principled way. By that measure Rocket Pharma is a pretty darn cool company. Rocket Pharma is running a CIRM-funded clinical trial for Leukocyte Adhesion Deficiency-I (LAD-I), a rare … Continue reading Going the extra mile to save a patient’s life
Hitting our goals: regulatory reform
Way, way back in 2015 – seems like a lifetime ago doesn’t it – the team at CIRM sat down and planned out our Big 6 goals for the next five years. The end result was a Strategic Plan that was bold, ambitious and set us on course to do great things or kill ourselves … Continue reading Hitting our goals: regulatory reform