The rules and regulations for your team to quality for the prize.
Josh Neubert, Managing Director
A project of Methuselah Foundation, a 501(c)(3)
Managed by the Institute of Competition Sciences
The Vascular Tissue Challenge (hereafter “Challenge”) is a $500,000 prize purse to be divided among the first three teams who can successfully create thick, human vascularized organ tissue in an in-vitro environment while maintaining metabolic functionality similar to their in vivo native cells throughout a 30 calendar day survival period. NASA’s objective for this Challenge is to produce technologies capable of creating viable thick (>1cm) metabolic tissues that can be used to advance research on human physiology, fundamental space biology, and medicine taking place both on the Earth and the ISS National Laboratory. Specifically, technology innovations may enable the growth of de novo tissues and organs on orbit which may address the risks related to traumatic bodily injury, improve general crew health, and enhance crew performance on future, long-duration missions.
Evaluation Criteria Summary
Produce an in vitro vascularized tissue that is > 1 centimeter in thickness in all dimensions at the launch of the trial and maintains >85% survival of the required parenchymal cells throughout a 30 calendar day period. Tissues must provide adequate blood perfusion without uncontrolled leakage into the bulk tissue to maintain metabolic functionality similar to their in vivo native cells. Histological measurement of the quality and amount of functional performance will be required to determine survival of parenchymal tissue. Teams must demonstrate 3 successful trials with at least a 75% trial success rate to win an award. In addition to the in-vitro trials, teams must also submit a Spaceflight Experiment Concept that details how they would further advance an aspect of their tissue vascularization research through a microgravity experiment that could be conducted in the U.S. National Laboratory (ISS-NL) onboard the International Space Station. This Spaceflight Experiment Concept will be used in evaluation for the CASIS Innovations in Space supplemental award, but will not have an impact on determining if a team has won the Vascular Tissue Challenge.
The Challenge will provide a First Place Award of $300,000 to the team that can first achieve all of the requirements as stated in the rules. Two runner up awards of $100,000 each will be provided to the next two teams to complete all requirements by the Trial Deadline.
New Organ (and New Organ Alliance): an initiative of the Methuselah Foundation serving as a coordinating brand for all tissue engineering efforts of the foundation to help advance technologies for patients in need of replacement organs and tissues.
Evaluation Criteria: The collective group of requirements that are necessary for a team to perform in order to win the Challenge awards.
Success Rate: the percentage of trials where the engineered, vascularized tissue survives, and continues producing the stated, natural functions of that tissue.
Trial: a 30 calendar day period of in vitro testing on a single tissue sample for performance on the evaluation criteria.
Survival: a tissue is defined to have survived if > 85% of the parenchymal cells have remained functioning and producing the stated, natural functions of that tissue at the conclusion of the trial with no more than 20% variability from a naturally functioning tissue.
Vascular Tissue Challenge Judging Committee (hereafter “Judging Committee”): a group of 5 or more subject matter experts who will review team trials and determine performance based on the Evaluation Criteria. Judging Committee will consist of 1 or more NASA subject matter experts, 1 or more Center for the Advancement of Science In Space (hereafter “CASIS”) subject matter experts, and 3 or more New Organ Alliance subject matter experts.
Trial Deadline – All trials shall be completed by September 30, 2019 to be eligible for the Challenge.
Blood Perfusion: teams may use in their Trials any type of perfusate that can provide oxygen, remove carbon dioxide, maintain pH balance, prevent edema and oxidative damage, and maintain tissue viability and function (e.g. Wisconsin Solution, Whole Blood or similar).
Each of the following items are requirements that must be met by the team and verified by the
Judging Committee in order for the team to win an award:
1. Tissue Survival – the tissue must be shown to have survived through the 30 calendar day trial as defined in Section 2. The tissue’s survival must be dependent upon nutrient delivery through blood perfusion of the tissue with no other outside support such as nutrient baths throughout the duration of the trial.
2. Perfusion –tissue shall include channels comprised of endothelial cells with active Blood Perfusion throughout the tissue for the duration of the trial. Blood Perfusion must be enough to keep the tissue surviving as defined in Section 2. Histological evidence must demonstrate fluid flow in the blood vessels without uncontrolled leakage causing edema of the bulk tissue. Perfusion must be demonstrated a minimum of three times during the trial: (1) ten calendar days into the trial, (2) 20 calendar days into the trial, and (3) 30 calendar days into the trial.
3. Thickness – The tissue sample shall be > 1 centimeter minimum thickness in all dimensions at the beginning of the trial.
4. Cell Types, Volumes and Functionality
5. Human Cells – All parenchymal and endothelial cells shall be human in origin.
6. Success Rate – Teams shall have a minimum 75% success rate in their trials with a minimum of three trials that meet all Evaluation Criteria. Examples of successful teams that will be awarded prize money are as follows:
7. Spaceflight Experiment Concept (SEC) – Microgravity has been shown to have potential benefits for understanding cell biology, materials, and microfluidics research that have the ability to accelerate tissue engineering technologies. To be eligible for the Challenge awards, a team must submit a written proposal for an experiment that could be conducted in the U.S. ISS-NL onboard the International Space Station to advance some aspect of their tissue vascularization research. The SEC must be submitted as an MS Word or PDF document no more than 10 pages long excluding figured and tables. It must detail the following items:
All teams shall follow the proper tissue care and use policies identified by their host institution, and adhere to the requirements for cell and tissue handling and human subject welfare listed in:
Teams must officially register with the New Organ Alliance management in order to be eligible to win the award. To officially register, teams are required to:
The Judging Committee shall conduct the review of each team's trials to ensure that all trial requirements listed below are met in determining the Challenge winner(s). The Judging Committee's determination on the success or failure of a team to meet these criteria is final. The judging process and evaluation shall be conducted in the following steps:
1. “Team Trial Application” Submission: To begin the judging process, each team shall submit a “Team Trial Application” to the Judging Committee. This document will be reviewed by the Judging Committee to ensure that the team’s trial will provide adequate data for the review of all Evaluation Criteria and that the team meets all Safety and Care requirements noted in Section 4 of the rules. The “Team Trial Application” document shall be submitted to the New Organ Management a minimum of 30 calendar days prior to the proposed start of the trial. The Judging Committee will provide a determination on acceptance or rejection of the application within 30 calendar days. The Team Trial Application must include:
2. “Team Trial Application”
Review: The Judging Committee shall review the Team Trial Application described by the team and make one of two determinations within 30 calendar days of application submission based on their review:
3. Trial Oversight Procedures: Upon review and acceptance of a Team Trial Application, the Judging Committee shall submit to the Team a “Trial Oversight Procedures” document. This document will define when the Judging committee will require on-site access to the Team’s trial location for review and evaluation of the Trial. The Judging Committee will, at a minimum, conduct an on-site evaluation at the conclusion of the 30 calendar day trial period, but may also require additional visits that will be defined in this document. The team will be required to provide access for the Judging Committee according to this Trial Oversight Procedures document in order to be eligible for the awards.
4. Final Trial Report: Upon completion of the team's trials, the team shall produce a final report for the Judging Committee including the results of all tests performed and the procedures used throughout the trial. The report must be submitted to the Judging Committee within 7 calendar days of the conclusion of the trial. The report must be submitted to the Judging Committee as either an MS Word or PDF document a maximum of 10 pages long excluding tables and figures describing the results of all trial tests.
5. Determination of Success: The team’s Final Trial Report and the Judging Committee's own on-site evaluations will be used to determine whether or not the team has successfully met all Evaluation Criteria. Determination of success will be completed by the Judging Committee within 60 calendar days from the conclusion of the team’s trial. Determination of success is at the sole discretion of the Judging Committee, and the review of the Committee is final.
Teams are required to complete the following milestones:
Submit an Intent to Compete – Teams wishing to compete for the prize shall first submit an Intent to Compete. It must be submitted no less than 30 calendar days prior to the Team’s submission of their Team Agreement.
Sign Team Agreement – Teams invited to be recognized as an Official Team competing for the prize(s) shall next submit a Team Agreement.
Complete Quarterly Progress Reports – Official teams must submit to the New Organ Alliance quarterly progress reports via email noting any work done towards winning the awards including funds spent and team invested time (total not individual).
Submit a Team Trial Application – Teams shall submit their Team Trial Application documents to the New Organ Alliance a minimum of 30 calendar days prior to their proposed Trial start date.
Submit the Team Registration Fee – Teams must submit the Team Registration Fee prior to the beginning of their first trial.
Conduct Trial(s) – Teams shall begin the trials on the date accepted in their Team Trial Application. Teams must also provide access to trial facilities as defined in the Trial Oversight Procedures provided to the team by the Judging Committee.
Submit Final Trial Report – the final report on the team’s trial must be submitted to the Judging Committee within 7 calendar days of completing the Trial.
Submit Spaceflight Experiment Concept – within 7 days of completing the trial, the team must submit to the Judging Committee a concept for an experiment that could be flown on the international space station that will further advance an aspect of their thick tissue vascularization research. This will be utilized in reviewing the team’s ability to receive the CASIS Innovations in Space Award, but will not have an impact on determining whether the team has won the Challenge.
Determination of Success – the Judging Committee will provide a determination of success to the team within 60 calendar days from the completion of the trial.
Eligibility – Any organization incorporated in the United States is eligible to register as a team for the Challenge. The officially recognized team shall be the organization and individual members listed on the signed Team Agreement. The Team Lead shall be limited to United States citizens or permanent residents only.
Disqualification - All teams shall adhere to the following guidelines to remain eligible for the Challenge. If at any time, a team is found to be in violation of one of these requirements, it shall be disqualified from further participation in the Challenge.
Disqualification of teams is at the sole discretion of the Judging Committee.
Appeal – Disqualified teams may appeal to the Judging Committee for reconsideration in order to compete for the prize(s). Appeals shall be considered for each team only once. For an appeal to be successful, the team must demonstrate to the Judging Committee that the committee has been misinformed of the actual behavior or falsification of data by the team. Appeals may only be made in regards to a team’s disqualification, not on the determination of success from the team’s Trial. The determination of appeal by the Judging Committee is final.
The Challenge will provide a First Place Award of $300,000 to the team that can first achieve all of the requirements as stated in the rules. A runner up award of $100,000 will be provided to each of the next two teams that complete all requirements by the Trial Deadline. Awards shall be provided by NASA directly to the winning team(s) in a lump sum payment.