Stem Cell Research Progress - Reeve-Irvine Research Center

2008 should bring some exciting accomplishments in the area of stem cell research. My friend Karen of CA for Cures, sent me a report from two members (Jennifer and Brian) of CareCure that recently took a trip to visit the lab of Dr. Hans Keirstead at the Reeve-Irvine Research Center (RIRC). They’ve written out highlights of the tour, which I’ve included below, along with a detailed PDF you’ll find here. The possibility of, “we’ll have a cure in five years”, is becoming more realistic.

“* The Reeve-Irvine Research Center (RIRC) has treatments in development that address all 3 phases of SCI; acute, sub-acute and chronic. Since SCI represents a population too small for drug companies to consider profitable, RIRC scientists, like Dr. Hans Keirstead, find characteristics that SCI has in common with other conditions. By grouping these conditions together, 2 important goals can be achieved for people with SCI:
o Create a large enough population to be profitable to big pharma;
o Shorten the trial length of each treatment. Instead of following a person with SCI for 10 – 20 years or more for data, they can use shorter trials in these other conditions.

* Safety studies with IP10 antibodies in ulcerative colitis should report soon. FDA approval for UC will allow this drug to be used off-label in Acute SCI. In animal models, as much as 70% return was noted when IP10 antibodies are given within 6 – 10 hours of SCI.

* In early 2008 Geron is planning to file an IND with the FDA and undertake safety studies using differentiated stem cells that form oligodendrocytes (these remylinate the spinal cord). The Phase I trial will be for people with new SCI, 1-2 weeks post injury.

Multiple studies addressing chronic SCI are underway at the RIRC:

* Animal testing with human embryonic stem cell derived motor neurons is underway. Human clinical trials await FDA approval – those discussions begin January, 2008. The first trials will likely be for infants with SMA-1, and then adults with end-stage ALS. This treatment is also for chronic SCI, without limit to the age of the injury. Decades-old SCIs may benefit from the treatment. The Geron experience taught Dr. Keirstead and team, which is moving the hESC motor neuron therapy forward, a great deal about the FDA approval process and they have been able to streamline their processes to move through the FDA system faster. This will be beneficial to the chronic trials.

* RIRC Director, Oswald Steward, is currently testing FDA approved drugs in chronic cervical SCI models. These drugs were developed for other applications, like heart disease and cancer, but have been found to be neuro-protective in fish models. Dr. Steward is testing 7 drugs now, but has many more ready to go. If any of these show efficacy in rat models, we can very quickly, in a matter of months, go to humans in a Phase II trial because the FDA has already determined them safe.

* Dr. Kim Anderson works with care issues such as sexual dysfunction and the metabolic effects of SCI that make us more prone to diabetes and other conditions. She discussed her current pilot study regarding diabetes in the SCI population.

* We have often talked about how funding is THE obstacle to curative therapies. Dr. Keirstead was careful to point out that funding is not the only issue. FDA approvals also play a pivotal role in how fast or slow a therapy will be tested

* If FDA approvals go as planned, we can reasonably expect chronic SCI clinical trials in humans in 2-3 years with treatments potentially available in as few as 5 years. These predictions are dependant on several factors: funding; FDA approvals and efficacy in humans to follow previous animal models.

* Research for Cure accepts donations for RIRC and Dr. Keirstead.

* Hopefully, everyone reading this will be inspired to raise funds and awareness for SCI research. Tania Cusack and Dr. Maura Hofstadter are the contacts at RIRC that can help with fundraising and research questions.”