Clinical trials are an essential step before getting to market. And we are quickly approaching the time when the preiminary work has been done before the human trials. A number of other factors are important to point out. For example a little self selection is not a large enough problem that would completely contraindicate a study designs. The factor is essential in some cases but here recruitment can be simplified for human clinical trial. Similarly a control group is not meaningful for most paramaters or a large control population is easy to obtain, further simplifying study design issues. But most importantly the procedures are relatively easy to implement with low relative risk as the invasiveness is less than in other surgeries. And there is an additional benefit in that, in part because they can be carried out relatively inexpensively and there exists a large diverse population of candidates we may be able to learn important insights applicable and helpful to the more general growing field of regenerative medicine with less risk in less time. We thus see this as a potential step that helps gather information potentially fundamental to other organ regeneration breakthroughs.

Our citizen science crowd funded group is taking all the preparatory steps to make sure we rapidly get to the stage where one can receive a safe and effective new biological tooth made from their own cells in a simple dental procedure. We are doing this by connecting the community, compiling the world’s knowledge on the subject, joining heads in an open manner to improve the chances of success, helping scientists access more resources of every sort, designing clinical human trials, recruiting participants in carrying out the procedures as well as volunteering to be part of the experiments, and generally advocating for the field and letting the world know what we are doing.

Many studies in the dental world involve animal models, especially rodents. However rodent teeth and bodies are quite different in a number of different parameters. Other animals also have differences with humans in teeth formation. While animals studies have contributed to a lot of knowledge it doesn’t always translate perfectly. In this case we have already demonstrated the development of teeth with a couple of animal models, and the key thing is to get to understand how this can work for humans with autologous stem cells if at all possible.  There are some hurdles here. Millions of people are suffering and are desperately waiting for these types of solutions to become available. In addition when experimenting with these types of solutions we have reduced risks compared to other science with humans because the procedure is relatively simple , the operations are not more invasive than existing methods, we are not proposing untested or dangerous combination of systemic drugs to  be involved and the profile of the person who will likely not encounter problems can be preselected because there is less need for control or blinding for some study purposes. All these factors point to getting to human tests sooner. Finally while there are still a few important preclinical trials that ought to be explored, the knowledge from diverse investigations is beginning to synergize and accelerate pointing out that the time is now to start to get geared up for trials so they can be underway a few years down the road. 

No way. Not any of the above. Nothing we say here on this website is medical advice or should be construed as such. And we recommend that you talk to your medical and dental specialists regarding problems you are experiencing and possible treatments. For those who wish to participate in human clinical trials some of them may be asked to take extra efforts to maintain certain oral tissues prior to enrolling. Candidates will be discussing their specific situation with a medical specialist and in that situation may need to consider refraining from removing existing teeth, making extra efforts to maintain or restore gum, bone or root health of any existing tissue using various methods and/or to medically bank oral tissues that have been broken or removed.

There are multiple legal and ethical considerations when deciding to implement a human trial. Different countries have different regulations and practices each with their own advantages and disadvantages. Two paramount issues are the safety of participants and ability of others to later rely on the solidity of the science. We know there is a broad demand for this type of a human trial so we are also taking this factor into consideration, when considering location and timeline. As a community we will also exploring steps to ensuring there is inclusivity for people across the socioeconomic spectrum and will create some form of sliding scale or stipend system to support people who would like to be participants but simply might be constrained to travel or do not have the economic means to be put on the orginal founding funders list for example. What we have going for us is that we hope the process can be done with autologous cells which means greatly reduced profile of risks and problems and thus potentially easier regulatory hurdles. Also the procedure doesn’t require any very advanced dentistry so it is can be accomplished with most dental partners who wish to participate.

I unfortunately had some tooth loss despite consistently taking care of my teeth in the usual ways. I felt a real strong sense of loss. None of the dental solutions although I appreciated the choices, sat right with me. I didn’t want implants, I wanted to feel whole again with all my parts of my body. I wondered can it be that I am the only one that feels this way? As a cellular scientist I wondered what values the teeth might have other than just biting and began to learn. I discussed these thoughts and feelings with my close ones from time to time. My partner also had tooth loss and experienced a similar sense of loss. And I began to realize how we weren’t alone and just how big the problem of not being able to grow teeth was. There were massive inadequacies with current dental solutions. I thought my sense of loss might pass with time, so I just allowed time to pass to see what occurred, but the feeling of missing a full set of teeth remained with me and eventually the feeling of loss turned into a sense of determination and responsibility to actively see if I could change the situation. Since in my real job I had been working with enamel cells, I realized that structural problems with the funding mechanisms in science could lead to delays in translating breakthrough insights and capabilities into helping people. I, around this time discovered a ton of people really want to do this, so together, my intention, is that we can now cut through the red tape and accelerate the steps necessary to getting to a safe and functional biological tooth for whomever wants one. I invite everyone to Join Us today and make the future of dentistry happen . In the dental science world its unusual to build an initiative powered by citizen science, but that is the approach I have chosen because it seems the most direct way to drive momentum and make sure we get to the goal.

All participants in clinical trials are volunteers who freely decided to participate after taking the time to go through an informaitonal process and they of course have the right to withdraw from a study at any time. You can withdraw, or decide to not participate at all. It always remains your choice what to do with your body and your time.

All trials are different. The clinical trial sponsor may pay for the new treatment, extra tests, and extra doctor visits as needed for the trial. Funding for clinical trials can come from various sources, including: Governmental agencies, A public or private medical company ,Non-profit foundations or medical centers.

In this case we are aiming to set it up so that costs are covered completely by our community organization but at this point we can not exclude travel expenses yet as we havent figured out yet how we will distribute our clinical centers. We will get back to you on this subject as soon as we know more.

The idea is an old one, and modern researchers have been working on this for decades. This community building website has only been completed in April 2023. So we are currently in Prelaunch as they say. Our Launch date is August 2, 2023 when we hope to initiate working full time on the project .

Give now – please give now, Without your help we cant make it a reality. We need immediate reoccurring monthly donors, and study participant candidates, in order to grow a critical mass for getting the message out and leveraging funding. We want people to give us a try, and happily beecome a dedicated community ready to make small investments consistently and commitedly for the next 3-5 years to get the snow ball effect going.

Sacrifice a trip to the cinema each month, or an entertainment subscription and donate to this  cause. Let your close friends know the sacrifice you are making or the excitement you feel.  For those who aren’t sure, try us out for a year and then look at what we achieved and our trajectory.

We need important funding to competently and carefully plan the many important components of the initiative. And we are doing everything was can so that the human trials will trial a procedure that will be successful.

Each and every person in a clinical trial plays a powerful role but the decision to join isn’t always an easy one. If you do make the choice, the understanding is that tooth loss and its ensuing mental and physical challenges touch the majority of people.

The intention is that participating in human trials leads to a revolution that promotes healthy ageing and reduces the burden of mental and physical illness for this generation immediately.

If you feel the urgency of cause take an initial step to join us today. Together we will change the course of dentistry for generations to come.

Not yet: We hope to do so and will provide access to our timeline to our supporters/members as it develops. Right now we are just building the framework for a timeline based on principles.

Taking the enormity of work involved in organizing the preliminary scientific research and the organizational capacities in this type of endeavor into account we think that it would be a true sort of miracle to make the trials happen starting in 2 years. On the other hand we feel less than 7 might be an aggressive but doable goal. Particularly so if we get lots of support early on, which would naturally accelerate the timeline.

We will be launching the trial just as soon as we have determined a clinical approach and experimental design and logistics that we feel is very likely to be successful, as well as safe, of course. Before that there is a ton of work on preliminary scientific research, on organizational capacity, on aligning partners and on advocacy and fundraising, among other important functions.

The first step involves dedicated infrastructure and expertise. Our launch we hope will prove our hunch that there is enough of a demand by inspiring enough supporters and funding so we can have basic dedicated organizational infrastructure for the initiative.

With dedicated ongoing infrastructure will we be able to consistently do work on the steps that get us closer to human trials.

Looking at what we need to have an adequate propensity to be successful with the trials, we currently have a few scientific hurdles we need to work intelligently and creatively around in order to be ready. For example right now we don’t have the know how to shape the crown of any tooth that grows and roots well in the gum. Yet crown shape is an important factor for a tooth. There are experiments needed to get over hurdles with using autologous cells and there are a handful of other issues as well.

In terms of building public crowd sourced community and capacity to get resources to scientists when they need it, we also have short term goals such as summarizing the literature in a way that’s accessible to everyone, building helpful platforms for the world’s best scientists, making content that attracts and informs people and media and helps create productive conversations as well as driving and leveraging visibility.  These types of activities take specific steps that will be accomplished but need regular ideating, implementing and nurturing by inspired and capable talent.

Not made yet.  We do have a framework though. The compass to understand our framework is not just speed but leverage. The orientation is to seek high return on investment for any resource.

Delivering on time and as promised must be central to our everyday activity. It is still early to specify a budget because there are so many unknowns we have to figure out. With this type of initiative to develop a transformative technology, this is normal.

Organizationally we need to figure out equipment costs and have discussions with more laboratories, and understand logistic options for trials and make decisions regarding everything. We are investigating various possibilities in numerous categories of our action plan.

We will endeavor to make practical choices based in the right strategic framework. One way of dealing with certain costs, risks and challenges is to focus on leverage. Part of that is to create partnerships and recognize opportunities for synergy.

We want to quickly generate “pilot, seed, bridge and translational funding” to key research partners we identify. This provides more stability to top-class researchers – ensuring we can keep some of the world’s best scientists working to grow teeth and revolutionize dentistry and helps keep research focused on our mission. Until now this has been a problem. Our hope is that funding enables them to uncover evidence which in turn allows them to apply for larger funding from other sources, such as the NHS, NIH, universities and other research and grant making organizations. This is part of our aspiration and the inspiration. No glut, just the right amount of funding to adequately support the right talent and tools to get the job done.

In addition to being committed to making us get to our goal in a brief timescale science wise we think its important to shoot for an estimate that every $1 donated to our scientists will leverage at least $5 of funding in five years’ time.  

This means, for example, that every small grant of $1,000 has the potential to leverage $5,000 worth of funding from some of the world’s most prestigious medical funders and anonymous gift makers. Stay tuned, when we actually have financials and developed pipelines to specific subset scientific and logistic goals to the human trials, we will communicate them so you can see the impact of your contributions and we can improve.

It might be unethical and in some places illegal to offer payment for trial participation but compensation is common in some countries. In our case we rely on the your support to make sure we can get to the stage that we can conduct the human trials. Its a community funding model to progress the science. For some who might otherwise like to contribute by participating in the trials, it might be difficult to finance, travel or free the schedule. We need to think through the inclusiveness aspects and propose a way to accommodate these types of issues. We will ask our community about which direction we ought to take when it comes time to make a decision about how to accomplish that.

Trials have costs of their own often in the tens of millions. That being said we are expecting to take a much more cost effective model because we think this field offers that opportunity. We will be able to transparently identify what the costs are and deliver on a plan for how it is financed.

Looking down the road we think its essential that the implementation of a grown tooth will be competitive with implants or other existing dental solutions, possibly with a small premium at very worst.

In the European Union and the United States. We haven’t incorporated yet as a non-profit because we are studying options.

We don’t know. The absolute minimum amount of time it would take to arrange the information, do some preliminary studies and design and organize the trial is about 2 .5 years, however an accelerated time table that’s more realistic is probably 5-7 years. We are organizing on the principle that we would like to get the trials off the ground during the 5th year at least.

We don’t have the eligibility, inclusion and exclusion criteria fully identified yet. Generally the idea is that to participate you will just need at least one missing tooth and be willing to go through the informed consent process and be able to participate at one of our clinical centers. Informed consent is a process of learning the key information about a research study before deciding whether one will participate or not.

Until we have a protocol down its still early for us to identify a list of risks but we will continue to explore this before that time and provide our findings to the community as we do here. It is the absolute responsiblity of the trial organizers to make sure risk is well understand by all participants and this will be an ongoing responsiblity. Informed consent is an ongoing process.

There will be multiple risks.  Similarly to the risks found at a dentist chair when gum tissues can get infected for example there will be procedural risks but in an experimental trial there are novel circumstances that add additional risks.

This has never been done before. Currently we are not sure how we will make the tooth form a crown that is in the correct shape in its location for function and aesthetics.

Additionally although there is reason to belieive full root integration will occur we don’t actually know this from human data yet.

Also we have yet to see how new teeth will work and function over time in the mouth.

Finally there are many basic questions unanswered about how stem cell biology works and how it affects the whole organism. As it is, there are no theories or information indicating that there will be reduced healing potential in other tissues or increased chances of tumors. On the contrary and that is why autologous (harvested from your own body) stem cell therapies are already legally conducted under certain protocols for many body parts all over the U.S. , in the EU and across the world. Autologous stem cell use eliminates the need for any special authorization and they avoid many problems and thus have a tremendously reduced risk profile. And that is therefore why this is our first choice as an approach to recreate tooth. But still its a very new field and so we think it merits to look into it and will do so.

Informed consent a process where we learn key information about a research study before deciding whether to participate. The informed consent process involves talking to a doctor, dentist, or other research team member about the study and looking over the consent documents part by part.

During the consent process, you learn about the study’s intention, what you will be asked to do before and during the study, how long the study will take, potential benefits and risks you may experience and often other aspects as well.

It is important to point out that it is absolutely the responsiblity of the trial organizers to share information regarding risks  both unknown and known with absolute transparency. Similarly at all points your choice to participate or not should be encouraged freely. It is a personal choice and while medical professionals can provide valuable information your decision is the only one that ultimately matters when it comes to your body. If you wish to consult with alternative medical professionals or advisors before making a decision, you absolutely will be encouraged to do so. If you have questions that the trial organizers can not answer on the spot then it is their duty to try to find the answer as best as possible and get back to you regarding that question.

You will be encouraged to ask any questions you may have about the study. If you decide to participate, you will be asked to reread and sign the consent form. However, the informed consent process kees going even after you sign the form. The research team or clinical provider must alert you when changes occur, when and if new risks are identified, or when new knowledge from the ongoing experiment or other source is gained that may change the risk-benefit ratio. It will remain up to you to decide to continue your participation based on your considerations.

People who participate in experimental trials have the potential to help many people through their collective contribution to science. They also take added risks and spend time in the process. Sometimes they benefit from the novel treatment and other times they do not. Their personal health and wellbeing, the wellbeing of their loved ones and the wellbeing of society are all important motivations in the decision to participate or not in a clinical trial.

Currently we have a few immediate needs. We need a small team of at least 2 and up to 4 dedicated capable talents working on the project full time. We need to set up systems of communications online so we can harvest the collective brain power, funding and network of the supporters and keep it growing in a scalable way so that we can achieve our aim.

We need to review the existing data in a comprehensive manner and provide a simple understandable layman’s popular science explanation of the state of the art.

We need to carefully design the studies including the auxilary studies and the human trials phases 1-4.

We need to foster conversations with scientists and others who can consult productively and contribute important insights that will prevent certain scientific challenges from cropping up later. We need to create a platform that supports the needs of the scientific community in this field and makes supports collaboration and synergy.

We need to create the network of dentists and oral surgeon specialists who will partner with us on the trials. We will need to hire lawyers if we are not able to find an experienced team to help us pro-bono. Similarly for clinical trial specialists to consult with us on planning and regulatory issues.

We will need to make sure we have good visibility for potential partners and grantmakers who would like to join our mission. We will likely invest in some cost-effective social media type tools as well as community building events. We may decide to spend on a form of award to leading scientists to further the profile of the field and incentivize activity.

That describes alot of what we will do with contributions.

The primary benefit of being a member is helping society through efforts to develop an industry transformative innovation that has a huge impact on everyone’s quality of life.

For those also wanting to know what types of services and informational products we are developing for community members please see each of the donation levels.

Loss of teeth is massively prevalent and the incidence of poeple losing teeth each year is so high. One might say that it is a relatively silent epidemic with serious physical and mental burden it brings robbing people of wellbeing.

The importance of our work may not just be limited to oral health. There are reasons to believe that because trials for growing human teeth have a more favorable benefit to risk profille as well as recruting profile than some other areas of regenerative medicine  that new insights that will help develop other organs will come to fruition faster.

Your family members and loved ones may well become direct benificiaries because we accelerated this initiative. When there is collective demand it needs to be given a voice through leadership, connection and organization. We hope that process in itself will inspire and touch people’s lives positively.

The body has cells with the potential to grow into whole organs. The tooth pulp among other tissues contains cells and factors that facilitate this. Given the right environmental stimulus the body’s own cellular activity can be coaxed to form a tooth again.

Not in people yet.