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The Studies 

As of spring of 2018, over $5 million has been raised from grants, private and corporate donations, and various fundraising activities and events. These funds have brought the research its position as the global leading project developing an autologous dopamine neuron replacement therapy for Parkinson’s disease. 

Budget

Currently, the Foundation and the scientific team is seeking funding from a wide variety of resources. We estimate needing $10 million to reach the IND application targeted for late 2019 with clinical trials to begin early 2020.

Some of the sources for funding we are working on are:

  • Grants – US Government, state and local government, foundations. 

  • Corporate funding and donations.

  • Private donations. (As of Spring 2018, approximately 50% of our funding has come from private individuals who support this effort.)

  • PR and Marketing Campaigns

As of spring of 2018, over $5 million has been raised from grants, private and corporate donations, and various fundraising activities and events. These funds have been allocated prudently and have brought the research its position as the global leading project working towards an autologous dopamine neuron replacement therapy for Parkinson’s disease.

Our priority is the completion of this therapy as quickly (and safely) as possible.

To be able to best raise the necessary funds, we have elected to not only 

  • increase our ability to apply for various grants from new resources thanks to no longer being underneath a higher and restrictive overhead environment, 

  • to provide the shelter of a foundation for tax-deductible donations 

  • also provide investors the platform to contribute towards getting this research project out there to those who need it right now.

Road to Clinical Trials

Summit for Stem Cell Foundation, in collaboration with the scientific team, is focused on exploring every possible funding source. Our goal is to file our pre-IND application with the FDA late 2018. 

What is the “pre-IND” meeting?

The pre-IND meeting is a critical step in which we communicate our plans to obtain permission from the FDA to initiate a clinical trial. The pre-IND maps out the final studies, called “IND-enabling” studies that will lead to the filing for our IND (Investigational New Drug) approval.  

We held our pre-pre-IND meeting (an informal version of the pre-IND) in 2017. This interaction with the FDA has helped us guide our studies over the last year.

What is the “IND”? 

IND is the acronym for Investigational New Drug. The United States Food and Drug Administration’s (FDA) Investigational New Drug program is the means by which permission is obtained from the FDA before a marketing application for the drug/treatment is approved. The FDA reviews the IND application for safety assurance to protect research subjects. Once the application is cleared, the drug/treatment can enter Phase 1 of clinical trials. Recently, changes in policy at the FDA were introduced by the 21stCentury Cures Act (Cures Act) to fast- track new and innovative treatments. Under the Cures Act, a Regenerative Medicine Advanced Therapy Designation (RMAT) will expediate the journey to clinical trials of our autologous dopamine neuron treatment.

What is the 21stCentury Cures Act (Cures Act)?

The 21st Century Cures Act, signed into law in December of 2016, is designed to help accelerate medical product development and bring innovations to patients who need them faster and more efficiently.

https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/default.htm

What is Regenerative Medicine Advanced Therapy (RMAT)?

As described in Section 3033 of the Cures Act (https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm), a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if:

a. The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination products using such therapies or products…

b. The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition.

c. Preliminary clinical evidence indicates that the drip has the potential to address unmet medical needs for such disease or condition.

Our research project meets all 3 of these criteria.

Clinical Trials Process

Clinical Trial Phase I - Pilot Study:

It is our plan to begin with a small clinical trial commonly known as a “Pilot Study”. The Pilot Study will consist of a small group of pre-selected individuals.  

 

Clinical Trial Phase 2:

Following the Pilot Study, it is our plan to open the study up to a larger contingency.  

Public availability: 

Thanks to new policies at the FDA, the autologous dopamine neuron replacement therapy will have an accelerated journey to Parkinson’s patients worldwide.

How can you participate in the clinical trials?

The inclusion criteria for participation in our planned clinical trial for patient-specific dopamine neuron replacement therapy has not been finalized. Please follow Summit on social media and sign up for our newsletter to stay up to date on the latest developments. If you would like to indicate your interest in participating in a future clinical trial, please fill out the information below: