Deja you: human cloning generally legal in the US

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human cloningOne of the great areas of confusion over the human cloning development this week is whether human cloning is legal or illegal.

With few exceptions, human cloning in general is legal in the US.

More specifically, therapeutic cloning of the type done in Oregon to produce embryonic stem cells (ESC) is legal in most states in the US including California. Just a handful of states ban therapeutic cloning.

At the federal level therapeutic cloning is legal.

How about reproductive Star Wars kind of cloning? The type of cloning that makes actual people? About a dozen ban reproductive cloning, but by far most do not.

There is also no federal law prohibiting reproductive cloning.

The FDA has stated that it believes it has jurisdiction over the process, but that does not make the process illegal. In fact, someone could clone a human being in the US without the FDA’s permission and it still would not be necessarily illegal.

We have seen from the FDA’s frustratingly circumspect behavior with dubious, non-compliant stem cell clinics as well as IVF clinics that just because the FDA says it has regulatory oversight power over a given process does not mean that those who go ahead and do that process without FDA permission will get into legal trouble or even any trouble at all. In fact, to the contrary, most of the time the FDA takes months if not years to react to non-compliant biologics-related activities and does so very cautiously.

What this means is that if a lab cloned a human being, the FDA could first of all do nothing to prevent it and second of all would probably not take dramatic action against the cloner.

Instead, I predict the FDA would visit the lab (assuming they could find it) and the FDA may after the fact tell the people they could not clone again, but by then it is kind of too late, right?

Also of relevance, but indirectly, is the fact that states vary substantially in their laws regarding compensation for egg donation by women, but my hunch would be that human cloners would not care much about complying with state laws in this area.

The bottom line is that generally in most of the US, there is no legal or insurmountable regulatory obstacle to human cloning. 

Striking improvement in vision in one ACT trial participant

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advanced cell technologyAdvanced Cell Technology (ACT) has confirmed that one of the patient in a clinical trial that it is running for treatment of macular degeneration, the leading cause of blindness worldwide, has shown a striking improvement in vision.

The patient reportedly had 20/400 vision prior to treatment and now has 20/40 vision after treatment.

ACT uses an embryonic stem cell-based therapy composed of retinal pigmented epithelial cells.

The improvement in vision is unlikely to be due to chance, however it is still unclear how promising this might be from a larger perspective. Indeed the company itself says:

ACT cautions that the improvement in the patient’s vision reported in this press release may not be indicative of future results of clinical trials of the RPE cells derived from hESCs.ACTC stock

Still, this is at the very least, encouraging news, but one patient does not tell the whole story.

For more, check out my interview with ACT CEO Gary Rabin.

The stock is up 17% just today so far.

I do not own stock in ACTC or other related companies.

Top 5 human reproductive cloning talking points dissected

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Yesterday’s report of human therapeutic cloning to make embryonic stem (ES) cell lines is a big deal. I support the work and I believe it is very important.

People’s reactions to it vary wildly depending on their agendas of course.

This post is a no-nonsense overview of the main points.

My overall point. This is just one paper folks. It’s a turning point paper for the stem cell field to be sure, but there is a great deal to still be learned about this technology so I’d recommend against taking extreme positions any time soon on human therapeutic cloning. In other words, don’t make the classic “Dr. Oz” mistake here. Dr. Oz famously got overexuberant about iPS cells so that he declared hESC’s unnecessary and the “stem cell debate dead” on the Oprah show. That was 7 years ago and the debate is still not dead.

Don’t make the same kind mistake here by going to one extreme or another. Also keep in mind that on day one of the iPS cell era in the stem cell field we had a huge number of misconceptions because we simply had so much to learn. Same is true here.

So keeping this all in  mind, here are the key talking points bouncing around on the Internet about yesterday’s cloning news and my frank reactions to each.

  • Talking point 1. Human SCNT ES cell cloning means that cloned babies will be bouncing out all over the place anytime now.
    • Nope.  It could happen in as short as 5 years, but it is still probably going to be technically tricky and could end up taking a decade or longer.
  • Talking point 2. Human SCNT ES cell cloning means nothing about human reproductive cloning. Don’t worry about that at all! No connection.
    • This is overly simplistic.  We shouldn’t panic (see above), but yesterday’s story does of course relate to human reproductive cloning and it is a real, deeply serious concern longer term. Some crazy person will try to clone humans. It’s inevitable in the coming decade or so and this paper unintentionally has a connection to it.
  • Talking point 3. Human SCNT ES cell cloning means very little since we already have iPS cells. Why did anyone even bother doing this?
    • That’s an oversimplification. My bet at this (admittedly very early) time point is that in the long haul (and we are in a marathon, not a sprint) that we end up using all these different types of cells for different applications. I predict that SCNT hESCs will have therapeutic benefits.
  • Talking point 4. Human SCNT ES cell cloning means IVF-based hESC lines won’t be needed.
    • False. SCNT lines are probably going to be better quality than iPS cells, but worse than IVF-based hESC lines. We’ll see once we have more data.
  • Talking point 5. Human SCNT ES cells will soon be competing with and even possibly replacing iPS cells in many applications.
    • That’s offbase. While I still personally believe that iPS cells are not 100% perfect, we simply cannot judge SCNT hESCs based on one paper. For all we know they have many issues of their own. In addition, I want to stress that I don’t believe that iPS cells have to be 100% perfect to be incredibly powerful therapeutically and traditional hESCs (not made by SCNT) are not 100% perfect either. Further, even if clinical potential of SCNT hESCs is expanded and realized in some ways, it’s going to take time (i.e. years) even to get off the ground. The first iPS cell-based clinical trial could, in contrast, start as soon as next year (2014).

Human cloning successfully makes embryonic stem cells

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For the first time ever, scientists have successfully used somatic cell nuclear transfer (SCNT) via the process of therapeutic cloning to generate normal human embryonic stem cells (hESC).

Knoepfler Diagram Human Cloning

Recall that there are two kinds of human cloning: therapeutic (which is reported in the new paper discussed in this post) and reproductive, which is making an actual new person with an identical genome to an existing person. The latter has never been achieved, but some of us are worried it is coming sooner than most imagine.

Shoukhrat MitalipovToday’s paper (Masahito Tachibana, et al.) reporting therapeutic cloning, entitled “Human Embryonic Stem Cells Derived by Somatic Cell Nuclear Transfer” was published in Cell by a team led by Shoukhrat Mitalipov (left) at Oregon Health Sciences Universities (OHSU).

It sure seems real this time too unlike 9 years ago with Woo-Suk Hwang.

Human SCNT

The press release (PR) from OHSU begins “Major Advance Provides Human Embryonic Stem Cells for Personalized Medicine” and continues:

Somatic cell nuclear transfer (SCNT) is a technique in which the nucleus of a donor cell is transferred to an egg cell whose nucleus has been removed, generating embryos that are almost an identical genetic match to the donor individual. For the first time, a team of scientists has used SCNT to produce human embryonic stem cells (hESCs). This milestone, published by Cell Press May 15th in the journal Cell, opens up new avenues for using stem cells to understand patient-specific causes of disease and for developing personalized therapies.

A very important part of the paper is the validation of the SCNT-produced hESC lines, which in Figure 6 (see image above at right) looks pretty thorough and solid.

Could SCNT-produced hESC could in some cases fill in where induced pluripotent stem cells (iPSCs) might be suboptimal. Indeed, the PR and the authors highlight this possible:

….concerns that this technique (meaning iPS cells) may generate unexpected mutations in the stem cells means that researchers are still keen to find ways to generate hESCs by other means.

Masahito TachibanaIn the discussion, the authors including first author Masahito Tachibana (pictured at left) further point out the potential problems with iPSCs.

So what does this all mean?

Overall, this paper is fascinating and a huge development, but this is a double-edged sword too.

On the one hand successful human SCNT could be used to develop personalized hESC from any patient for therapeutic use. This is very important, positive, and exciting.

On the other hand, the elephant in the room for this paper is the potential for future reproductive human cloning. Apparently there are still some technical obstacles to cloning primates including humans, but this seems like a step toward making reproductive cloning a reality.

What is the difference between reproductive and therapeutic cloning?

One is used to make people (or sheep or other animals) while the other, as reported in this paper, is used to make hESCs (or ESCs from other species) with potential therapeutic benefit. My diagram at the very top shows the methodological similarities and differences.

Bottom line? I hope that therapeutic cloning produced hESC turn out to be a new way for helping many patients. A big next step will be seeing other labs recapitulate this work.