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 FDA

 & Clincal Trials 

Understanding

Dopamine neuron (iPSC sourced)

The FDA and

The Regenerative Medicine

Clinical Trial Process

Updated: 08/30/2020

Summit for Stem Cell Foundation would like to help you better understand:

  • The FDA

  • Regenerative Medicine Process for PD.

  • The IND process (Investigational New Drug)

  • Autologous Dopamine Neuron Replacement Therapy (Research Project)

  • The Preparation Process

  • The Costs

  • Average Timeline: Pharma IND to FDA approval

If you wish to find information on any of the above documents simply click the QwikLink each phrase.

approved clinical trial process cannot begin until autologous dopamine neuron replacement therapy is completed. In the past we have shared a estimated timeline based on the information available at the time. The timeline has continually been adjusted for various reasons - including the advent of the COVID-19 pandemic. We realize this had been frustrating for many. Please understand that it is not the FDA, Aspen Neuroscience, the scientists nor Summit that is the  "bad guy" in this scenario. TIME is the foe for those with Parkinson's disease. Everyone involved with the research project has and continues to work with dedicated diligence to begin clinical trials as safely and efficiently as possible.


With that in mind, below is some information to help you understand the FDA and its policies to ensure a safe and dependable therapy...

The FDA

When will clinical trials begin for the research project: autologous dopamine neuron replacement therapy?

It is difficult to predict with any certainty when the clinical trials will begin.

 

The FDA approved clinical trial process cannot begin until autologous dopamine neuron replacement therapy is completed. In the past we have shared a estimated timeline based on the information available at the time. The timeline has continually been adjusted for various reasons - including the advent of the COVID-19 pandemic. We realize this had been frustrating for many. Please understand that it is not the FDA, Aspen Neuroscience, the scientists nor Summit that is the  "bad guy" in this scenario. TIME is the foe for those with Parkinson's disease. Everyone involved with the research project has and continues to work with dedicated diligence to begin clinical trials as safely and efficiently as possible.


With that in mind, below is some information to help you understand the FDA and its policies to ensure a safe and dependable therapy...

                            For REFERENCE: The typical timeline for a pharmaceutical drug to be publicly accessible.

                            The process for a pharmaceutical drug to receive FDA approval to begin clinical trials

                            typically takes 12+ years at an average cost of US$350 million. Once FDA approval is

                            received, the “investigative drug” then begins three phases of clinical trials:

                                         Phase I - Establishing a drug’s safety and profile (approximately 1 year).

                                         Phase II – Assess a drug’s effectiveness (approximately 2 years).

                                         Phase III – Determining a drug’s effectiveness and identify adverse reactions

                                                           (about 3 years).

                            Once Phases I,II, & III are completed, a 100,000+ page application is submitted for

                            processing which usually takes an additional 2.5+ years for the drug to receive final FDA

                            approval for physicians to prescribe.

 

 

However, the FDA is working to meet the unmet needs of people with diseases having no cure. Parkinson’s disease is a disease with unmet medical needs. Although the iPS cell-based therapy has not received its classification as of this date, the FDA has developed new policies to address the pace at which scientific discoveries in regenerative medicine are being made today.

Aspen Neuroscience is currently working with a newer FDA division called: “Center for Biologics Evaluation and Research (CBER)”. CBER is working with the Regenerative Medicine field to develop new policies to “expedite” stem cell-based therapies to meet patient’s needs and to meet the challenging pace of discoveries in science present. 

                            Fast Track Designation: to facilitate the development and expedite review of drugs and

                            biologics intended to treat serious or life-threatening conditions and that demonstrate the

                            potential to address unmet medical needs. 

 

 

 

                            The 21st Century Cures Act: modifies the FDA Approval process. The development

                            and bring new innovations and advances to patients who need them faster and more

                            efficiently.

 

 

                            RMAT designation: Regenerative Medicine Advanced Therapy (RMAT): a drug is eligible

                            for regenerative medicine advanced therapy (RMAT) designation if:

                                      1. 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 product using such therapies or products meeting FDA criteria.

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

                                           disease or condition; and 

                                       3. Preliminary clinical evidence indicates that the drug has the potential to address

                                           unmet medical needs for such disease or condition.

COMPASSIONATE USE / RIGHT TO TRY

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approved clinical trial process cannot begin until autologous dopamine neuron replacement therapy is completed. In the past we have shared a estimated timeline based on the information available at the time. The timeline has continually been adjusted for various reasons - including the advent of the COVID-19 pandemic. We realize this had been frustrating for many. Please understand that it is not the FDA, Aspen Neuroscience, the scientists nor Summit that is the  "bad guy" in this scenario. TIME is the foe for those with Parkinson's disease. Everyone involved with the research project has and continues to work with dedicated diligence to begin clinical trials as safely and efficiently as possible.


With that in mind, below is some information to help you understand the FDA and its policies to ensure a safe and dependable therapy...