July 10, 2020

The Niche

Knoepfler lab stem cell blog

REGROW Act 2.0 still no-go with big risks to patients & field

Mark Kirk REGROW ActThe REGROW Act is a bill that seeks to lessen the regulatory burden to accelerate getting stem cells to patients more quickly, but it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole.

The REGROW Act, which is sponsored by Senator Mark Kirk of Illinois, has had several incarnations, but the latest new one reflects some big changes so I’m going to call it REGROW 2.0.

A source provided me with a copy of REGROW 2.0 and it is surprising in a number of ways. Unfortunately the bottom line is that it is still a no-go because it would be so risky.

The original REGROW would have forced a conditional approval system on the FDA whereby still experimental stem cells could be given to patients with little data supporting this use.

REGROW 2.0 has dropped the extreme conditional approval so that seems like a good thing. Instead 2.0 focuses on accelerating approval, which on the surface also seems like it could be a positive thing. However, the devil is in the details.

Too broad on cell product type? The new version of the bill drops all requirements on the types of cells that would qualify including the previous filters for genetically modified cells. So anything goes for stem cell types in REGROW 2.0.

Too weak on medical conditions? The new version of the bill also would weaken in a really big way the standard requirements for accelerated approval for experimental stem cell products by the FDA. No longer would the patient need to be facing a very serious condition with unmet need such as a fatal illness, but now instead the acceleration could be used for many things that fit into the broader category it stipulates:

“the treatment of a serious condition for which the product is approved under this subsection may include a chronic, persistent, or recurring condition that affects day-to-day functioning without taking into account the availability or lack of alternative treatments.”

Devices mess. This could mean almost anything so REGROW 2.0 would put a big old loop-hole in there. REGROW 2.0 also still seems problematic related to stem cell devices as it is weak on the rules required for determining what can or cannot be used.

Stem cell clinics covered too? One of the other problems with both the original REGROW and its 2.0 version is that some of the not-so-good citizens within the stem cell arena may take advantage of its mandating of weaker oversight provisions.

FDA has issues but it’s not only problem. The bill also represents a philosophical shift toward the idea that the FDA is the only problem here with translation of stem cells. Yes, the FDA has some issues including a major lack of clarity and slowness, but it’s too simple to say the FDA is the only problem with the stem cell clinical translation arena.

For instance, experience so far teaches us that safe and effective cellular therapies are most often going to be very challenging at scientific and medical levels to produce and prove with convincing data that they are superior to the standard of care. Shortcuts around this rigorous standard help no one in the long run.

Who is writing REGROW and is there an industry connection? Even though Senator Kirk is the prime sponsor of the REGROW Act, the language of the bill certainly continues to feel like it was written by stem cell companies who want less oversight by the FDA. I wonder who exactly is the person or persons writing and rewriting REGROW? How much of a role if any does industry play in that?

Bottom line. What this all mean is that overall I still have to say “no” to REGROW Act 2.0 from my perspective. It’s too risky for patients and the field.

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