Document:

Exhibit 10.15

 

LICENSE AGREEMENT

AMENDMENT #6

 

WHEREAS, effective as of December 1, 2014,
and as further amended, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office
10399 West 70th Street, Eden Prairie, MN 55344 (“Miromatrix”) and Mayo Foundation for Medical Education and Research, a not
for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 (“Mayo”) executed a License Agreement (the
 “Agreement”) for Services as outlined in the Agreement.

 

WHEREAS, Miromatrix and Mayo wish to amend said
Agreement.

 

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

 

1.         
The Term of the Agreement shall be extended to February 28, 2021.

 

2.         
Miromatrix has agreed to provide additional funding of $400,000 for

 

extension described in #1 above. Accordingly, the attached
Exhibit B-4 shall amend Section 3 of the Agreement.

 

Except as specifically provided herein, the terms and conditions
of the Agreement shall remain in force.

 

IN WITNESS WHEREOF, the Parties have executed
this Amendment which shall be effective as of the last dated signature below.

 

	MIROMATRIX MEDICAL INC.	 	MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
	 	 	 
	By:	/s/ Jeff Ross	 	By:	/s/ Randall S. Jones
	Name:	Jeff Ross	 	Name:	Randall S. Jones
	Title:	CEO	 	Title:	Operations Manager
	Date:	2/27/2020	 	Date:	2/28/2020

 

     

     

    

 

	
     

                                                    Budget

     

    Pl Name: Scott Nyberg, MD, PhD

    MCR Funding Proposal Number: FP86573-Al-Al-Al-Al-Al-Al

    Sponsor: Miromatrix Medical Inc.

    Date: 2/27 /20

	Study Title: Amendment
    #6: Miromatrix/Mayo Transplantable Liver Project (Nyberg)

 

	 	 	Additional funding to extend 
 project through 2/28/21 **	 
	Personnel: $	 	$	206,744	 
	Dr. Scott Nyberg, Pl	 	 	 	 
	Bruce Amiot, Business Analyst	 	 	 	 
	 	 	 	 	 
	Lab Supplies & Internal Services: $	 	$	100,949	 
	Sub-Total $ 	 	$	307,693	 
	Indirects (30%) $ 	 	$	92,307	 
	BUDGET TOTAL $	 	$	400,000	 

 

Payment Terms: The total budget above will be payable in 4 payments of $100,000 each. The first payment of $100,000 will be payable upon execution of contract amendment #6. The remaining payments will be invoiced at the beginning of each quarter thereafter. In addition to the $100,000 per quarter, if more than 6 liver transplants are performed per quarter then an additional $16,667 per transplant will be added to the invoice in the subsequent quarter.

 

*
Salary and benefit rate information is confidential. Mayo cannot share individual costs or rate information, as this would be against
Mayo policy

 

**
This budget only reflects the additional funds that are being added with amendment #6.Exhibit 10.16

 

LICENSE AGREEMENT

AMENDMENT #7

 

WHEREAS, effective as of December 1, 2014,
and as further amended, Miromatrix Medical Inc., a corporation organized under the laws of the State of Delaware and having an office
10399 West 70th Street, Eden Prairie, MN 55344 ("Miromatrix") and Mayo Foundation for Medical Education and Research, a not
for profit corporation with an address at 200 First Street SW, Rochester, MN 55905 ("Mayo") executed a License Agreement (the
 "Agreement") for Services as outlined in the Agreement.

 

WHEREAS, Miromatrix and Mayo wish to amend said
Agreement.

 

NOW, THEREFORE, Miromatrix and Mayo agree as follows:

 

		1.	The Term of the Agreement shall be extended to December 31, 2021.
	 	 	 

		2.	Miromatrix has agreed to provide additional funding of $317,600 for extension described in #1 above. Accordingly,
the attached Exhibit B-5 shall amend Section 3 of the Agreement.
	 	 	 

		3.	Except as specifically provided herein, the terms and conditions of the Agreement shall remain in force.

 

IN WITNESS WHEREOF, the Parties have executed
this Amendment which shall be effective as of the last dated signature below.

 

	MIROMATRIX MEDICAL INC.	 	MAYO FOUNDATION FOR MEDICAL
		 	EDUCATION AND RESEARCH

 

	By:	/s/ Jeff Ross	 	By:	 
	Name:	Jeff Ross	 	Name:	 
	Title:	CEO	 	Title:	 
	Date:	2/26/21	 	Date:	 

 

 

    

     

    

 

Budget - Exhibit B-5

 

	
     

    Budget

     

    PI Name:     Scott Nyberg, MD, PhD

    MCR Funding Proposal Number: FP86573-A1-A1-A1-A1-A1-A1

    Sponsor: Miromatrix Medical Inc.

    Date: 2/25/21

     

	Study Title: Amendment #7: Miromatrix/Mayo Transplantable Liver Project (Nyberg)

 

	 	 	Additional funding to extend project through 12/31/21**	 
	Personnel:	 	$	137,485	 
	Dr. Scott Nyberg, PI	 	 	 	 
	Bruce Amiot, Business Analyst	 	 	 	 
	 	 	 	 	 
	Lab Supplies & Internal Services:	 	$	105,284	 
	 	 	 	 	 
	Sub-Total	 	$	242,769	 
	Indirects (30%)	 	$	72,831	 
	 	 	 	 	 
	BUDGET TOTAL (excluding fees)	 	$	315,600	 
	One-time, non-refundable fees:	 	 	 	 
	IACUC Initial Review Fee	 	$	2,000.00	 
	Total Fees:	 	$	2,000.00	 
	BUDGET TOTAL	 	$	317,600.00	 

	Payment Terms: The total budget will be payable in four payments. The first payment of $80,900, which includes the $2,000 non-refundable Initial IACUC Review Fee, will be due upon the execution of this contract for amendment #7; the second payment of $78,900 will be due on June 12021, the third payment of $78,900 will be due on August 12021, and the fourth payment of $78,900 will be due on November 1, 2021. Milestones of this sponsored research will include a minimum of 16 experiments according to two Mayo IACUC approved protocols [A0005683-evaluation of the ELAP device in a reversible model of ALF (12 experiments), A00003996-liver transplantation in pigs to compare donor grafts (4 experiments)] before the end of 2021.
	*Salary and benefit
    rate information is confidential. Mayo cannot share individual costs or rate information, as this would be against Mayo policy
	**This
    budget only reflects the additional funds that are being added with amendment #7.Exhibit 10.17

 

COLLABORATION AGREEMENT

 

THIS COLLABORATION AGREEMENT
(the “Agreement”) is entered into as of the 19th day of October 2015 (the “Effective Date”), by and between Miromatrix
Medical Inc., a corporation organized under the laws of the State of Delaware and having an office at 10399 West 70th Street, Eden Prairie,
MN 55344, (“Miromatrix”), and Icahn School of Medicine at Mount Sinai, a New York not for profit education corporation with
an address at One Gustave L. Levy Place, New York, NY 10029 (“Mount Sinai”), each hereinafter referred to as a “Party”
and jointly as “Parties”.

 

WHEREAS, Miromatrix and Mount
Sinai wish to enter a relationship whereby Mount Sinai will conduct certain research in collaboration with Miromatrix relating to Miromatrix’
decellularization/recellularization technology (the “Research”);

 

WHEREAS, Dr. Ron Shapiro of
Mount Sinai’s Recanati/Miller Transplantation Institute (the “Institute”) shall be Mount Sinai’s principal investigator
for the Research (the “Principal Investigator”).

 

NOW, THEREFORE, in consideration
of the mutual promises and covenants contained herein, and intending to be legally bound hereby, the Parties agree as follows:

 

		1.	Scope of Work.

 

		1.1	Mount Sinai agrees to use its best reasonable efforts to perform the Research in accordance with the Statement
of Work attached hereto as Exhibit A (the “Project”).

 

		1.2	Mount Sinai shall perform the Project in accordance with standards applicable to work of similar type
and scope to the Project performed by those skilled in the relevant art, as well as all laws and regulations that apply to such type of
work. Mount Sinai does not guarantee that any patent rights shall result from the Research, that the scope of any patent rights that may
result shall cover Miromatrix’ commercial interest, or that any such patent rights shall be free of dominance by other patents,
including patents based on inventions made by other inventors at Mount Sinai independently of the Research; furthermore Mount Sinai makes
no representations as to the commercial or scientific value of any results achieved through the Research.

 

		1.3	In consideration of the contribution of Mount Sinai to the Research, in the event that Mount Sinai successfully
executes the Statement of Work, Miromatrix agrees to give Mount Sinai the option to perform the next stage of studies for the Research.
Miromatrix further agrees to give Mount Sinai the first option to be the site for Miromatrix’ first in-human kidney transplantation
clinical trial under an agreement including commercially reasonable terms to be negotiated in good faith between the Parties.

 

     

     

    

 

		2.	Term. This Agreement shall be effective from the Effective Date and expire on December 31,
2017 (the “Term”) extendable by mutual written agreement signed by both Parties, provided that either Party may terminate
this Agreement by thirty (30) days prior written notice to the other.

 

		3.	Payment.

 

		3.1	Each Party shall bear its own costs for conducting the Project.

 

		3.2	Miromatrix agrees to provide Mount Sinai funding for any next stage of studies for the Research that takes
place at Mount Sinai, with an amount to be negotiated in good faith between the parties.

 

		4.	Materials Provided.

 

		4.1	Miromatrix shall provide certain materials in order to support Mount Sinai’s efforts associated
with the Project. These materials shall consist primarily of decellularized and partially or fully recellularized organs or organ constructs
(the “Materials”).

 

		4.2	All Materials shall remain the property of Miromatrix and shall be used by Mount Sinai solely for the
Project. The Materials shall be returned to Miromatrix or destroyed by Mount Sinai, as requested by Miromatrix, at the end of the Term
of this Agreement, upon early termination of this Agreement, or upon the written request of Miromatrix.

 

		4.3	The Materials shall be used with prudence and appropriate caution in any experimental work. THE MATERIALS
ARE PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. Miromatrix
agrees to defend and indemnify Mount Sinai from any and all claims and damages in any way arising from the acquisition, use, storage or
disposal of the Materials by Mount Sinai, unless such claim is due to negligence on the part of Mount Sinai.

 

		4.4	No option, license, or conveyance of rights, express or implied, is granted by Miromatrix to Mount Sinai
in connection with any Materials provided under this Agreement, except the right to use the Materials strictly in accordance with the
terms of this Agreement.

 

		5.	Principal Investigator. If, for any reason, the Principal Investigator is unable to continue
to serve as Principal Investigator, Mount Sinai shall designate another individual, subject to the approval of Miromatrix, to serve as
Principal Investigator of the Project.

 

     

     

    

 

		6.	Independent Contractor.

 

Nothing in this Agreement shall be construed to
create a partnership or joint venture between Mount Sinai and Miromatrix, nor shall either Party’s employees, servants, agents or
representatives be considered the employees, servants, agents or representatives of the other. Neither Party shall have any express or
implied right or authority to assume or create any obligation on behalf of, or in the name of, the other Party; or to bind the other Party
to any contract, agreement or undertaking with any third party.

 

		7.	Reports and Records.

 

		7.1	Mount Sinai shall provide Miromatrix with periodic (not to exceed quarterly) progress reports on the Project,
detailing, for example, work completed and results achieved, in confidence.

 

		7.2	Mount Sinai shall provide Miromatrix with a final written report within thirty (30) days following completion
of the Project or upon earlier termination of this Agreement, in confidence. Such report shall contain, in addition to other information,
documentation supporting all activities performed as part of the Project.

 

		7.3	Mount Sinai shall, at mutually agreed upon times, meet with Miromatrix representatives to discuss Project
progress, results and reports, in confidence.

 

		7.4	Subject to Section 9, Project results generated by Mount Sinai and Project data generated by Mount Sinai
shall be the Confidential Information (as defined below) and sole property of Mount Sinai (“Mount Sinai Results”). Contingent
upon Miromatrix’s compliance with Section 1.3, Mount Sinai shall grant Miromatrix, at no cost, the right to use and disclose Mount
Sinai Results for its internal research and product development purposes, regulatory submissions, publication inclusion, intellectual
property submissions pursuant to Section 8 hereinbelow, grant applications and marketing purposes, and for no other purpose. Project results
generated by Miromatrix and Project data generated by Miromatrix shall be the Confidential Information (as defined below) and sole property
of Miromatrix (“Miromatrix Results”), and Miromatrix hereby grants Mount Sinai the right to use Miromatrix Results solely
for its internal research and education purposes.

  

		8.	Intellectual Property Rights.

 

		8.1	For inventions and/or discoveries, whether patentable or not, conceived (as defined by U.S. patent laws)
and reduced to practice in the conduct of the Project at Mount Sinai under this Agreement (“Inventions”), inventorship shall
be determined in accordance with the U.S. Patent law and ownership shall follow inventorship:

 

     

     

    

 

		(a)	Mount Sinai shall own all right, title and interest in and to Inventions conceived and reduced to practice solely by Mount Sinai employees
under this Agreement (“Mount Sinai Inventions”). With the exception of Inventions relating solely to surgical techniques,
Mount Sinai hereby grants Miromatrix a worldwide, irrevocable, non-exclusive, royalty-free license to use such Inventions for non-commercial,
internal research activities. Mount Sinai shall disclose such Inventions, in confidence, to Miromatrix in writing before the end of the
Term of this Agreement.

 

		(b)	Mount Sinai and Miromatrix shall jointly own Inventions conceived jointly by employees of both Parties (“Joint Inventions”).

 

		(c)	Miromatrix shall own all right, title and interest in and to Inventions conceived and reduced to practice solely by Miromatrix’
employees or agents (“Miromatrix Inventions”). Miromatrix hereby grants Mount Sinai a worldwide, irrevocable, non-exclusive,
royalty-free license to use Miromatrix Inventions for its internal research and teaching purposes.

 

		9.	Publication; Use of Name.

 

		9.1	Mount Sinai and Miromatrix recognize the traditional freedom of all scientists to publish and present
promptly the results of their research. Mount Sinai and Miromatrix also recognize that exclusive patent rights can be jeopardized by public
disclosure prior to the filing of suitable patent applications. Mount Sinai agrees not to disclose Miromatrix Results. Mount Sinai also
agrees that first public disclosure of the Mount Sinai Results will be in accordance with the following. Mount Sinai agrees that Principal
Investigator shall submit each proposed first publication of Project results and Project data (“Manuscript”), before submission
to a publisher or other public disclosure, to Miromatrix for review. Miromatrix shall have forty-five (45) days after such submission
to notify Principal Investigator in writing of any Miromatrix Confidential Information appearing in such Manuscript and request its removal,
in which event Principal Investigator shall remove such Confidential Information prior to submission for publication or other public disclosure
of such Manuscript. Within said same forty-five (45) day period, Miromatrix may request in writing that Principal Investigator delay submission
for publication or other public disclosure of such Manuscript for patent filing purposes, for a period not to exceed ninety (90) days
from the initial disclosure of such Manuscript to Miromatrix.

 

		9.2	Miromatrix agrees not to use Mount Sinai’s name, or the name of any trustee, officer, faculty member,
student or employee thereof (or any adaptation of any of the foregoing), without Mount Sinai’s prior written consent, except that
Miromatrix may (a) list Mount Sinai as a collaborator relating to the Project and (b) to the extent required by law, may list Mount Sinai
as a collaborator in any other place. For clarity, name use permitted without prior
approval does not include use of Mount Sinai’s name as an endorsement of any Miromatrix product or service.

 

     

     

    

 

		10.	Warranty Disclaimers, Limit of Liability and Indemnification.

 

		10.1	NEITHER PARTY MAKES ANY WARRANTY, EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT
LIMITATION, WARRANTIES WITH RESPECT TO LIABILITY FOR INFRINGEMENT OF ANY THIRD PARTY INTELLECTUAL PROPERTY, THE CONDUCT, COMPLETION, SUCCESS
OR PARTICULAR RESULTS OF THE PROJECT, OR THE CONDITION, OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE PROJECT,
THE MATERIALS, OR ANY INTELLECTUAL PROPERTY OR JOINT INTELLECTUAL PROPERTY. NEITHER PARTY SHALL BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL,
PUNITIVE OR OTHER DAMAGES THEY OR THE OTHER PARTY SUFFERS OR ANY OTHER PERSON SUFFERS RESULTING FROM THE PROJECT OR THE USE OF ANY PARTY’S
MATERIALS OR INVENTIONS OR JOINT INVENTIONS.

 

		10.2	Miromatrix agrees to indemnify and hold harmless Mount Sinai, the Principal Investigator and any of Mount
Sinai’s faculty, students, employees, trustees, officers, affiliates and agents (hereinafter referred to collectively as the “INDEMNIFIED
PERSONS”) from and against any and all liability, claims, lawsuits, losses, damages, costs or expenses (including attorneys’
fees), which the INDEMNIFIED PERSONS may hereafter incur, or be required to pay arising out of or otherwise related to Miromatrix’
use of: (a) any Miromatrix Materials; (b) any information and reports provided to Miromatrix hereunder; (c) the Mount Sinai Results; or,
(d) any Mount Sinai Inventions or Joint Inventions, or any act or omission of Miromatrix, its employees, affiliates, contractors, licensees
or agents. Mount Sinai shall notify Miromatrix upon learning of any such liability, claims, lawsuits, losses, damages, costs and expenses
and Mount Sinai shall cooperate with Miromatrix in every proper way in the defense or settlement thereof at Miromatrix’ request
and expense. Miromatrix shall settle no action for which it indemnifies INDEMNIFIED PERSONS without Mount Sinai’s prior written
consent, with respect to statements implicating liability or fault on the part of Mount Sinai.

 

		10.3	Mount Sinai hereby agrees to indemnify and hold harmless Miromatrix and its officers, employees, agents
and affiliates from all liabilities, damages, costs, claims and expenses of any kind or nature, caused by Mount Sinai’s negligence
or willful misconduct in performance of the Project.

 

		10.4	Neither Party shall be liable for any failure to perform as
required by this Agreement to the extent such failure to perform is due to circumstances reasonably beyond such Party’s control,
including, without limitation, labor disturbances or labor disputes of any kind, accidents, failure of any governmental approval required
for full performance, civil disorders or commotions, acts of aggression, acts of God, energy or other conservation measures imposed by
law or regulation, explosions, failure of utilities, mechanical breakdowns, material shortages, disease, or other such occurrences. Either
Party so prevented from performance shall notify the other Party as promptly as reasonably possible given the circumstances preventing
performance, and shall resume performance as promptly as possible after such circumstances and conditions caused thereby cease.

 

     

     

    

 

		11.	Confidentiality.

 

		11.1	“Confidential Information” means any business, scientific, or technical information of either
Party, including but not limited to any information relating to either Party’s product plans, designs, costs, finances, marketing
plans, business opportunities, personnel, research, development or know-how, that is disclosed by one Party to the other during the Term
of this Agreement in connection with the Project. Confidential Information disclosed in tangible form shall be marked as “confidential”
upon disclosure or, in the case of oral or other intangible disclosures, shall be summarized in a writing that is marked “confidential”
and transmitted to the receiving Party within thirty (30) days of the intangible disclosure, provided however that failure to so mark
or summarize shall not alter the confidential status of such information if a reasonable person would recognize, by the content and/or
context of such disclosure, that the disclosure was intended as confidential.

 

		11.2	Each party may wish, from time to time, in connection with the Project contemplated under this Agreement,
to disclose its Confidential Information to the other Party. Each Party shall use such other party’s Confidential Information solely
for the Project and no other reason; each Party shall exercise at least a reasonable degree of care to prevent the disclosure of any of
the other Party’s Confidential Information to third parties during the Term and for five (5) years after the termination or expiration
of this Agreement, provided that the recipient Party’s obligations hereunder shall not apply to information that: (a) is already
in the recipient Party’s possession at the time of disclosure thereof; (b) is or later becomes part of the public domain through
no fault of the recipient Party; (c) is received from a third party having no obligations of confidentiality to the disclosing Party;
or, (d) is generated by the receiving Party independently of and without use of the Confidential Information of the disclosing Party as
demonstrated by the receiving Party’s written or electronic records created contemporaneously with such independent development.
In addition, the receiving Party shall also be permitted to disclose Confidential Information of the disclosing Party to the extent required
by law, court order, or other governmental authority with jurisdiction provided that the receiving Party promptly provides the disclosing
Party, to the extent legally permissible, with written notice of such requirement and cooperates, at the disclosing Party’s written request
and expense, with the disclosing Party’s legal efforts to prevent or limit the scope of such required disclosure.

 

     

     

    

 

	12.	Notice. Any notice or communication pursuant to this Agreement shall be sufficiently made
or given if sent by certified or registered mail, postage prepaid, or by overnight courier, with proof of delivery by receipt, addressed
to the address below or as either party shall designate by written notice to the other party.

 

In the case of Mount Sinai:

 

Mount Sinai Innovation Partners

Icahn School of Medicine at Mount Sinai

One Gustave L. Levy Place, Box 1675

New York, NY 10029

Attn: Vice President

 

With copy (for legal notices only) to:

 

Office of the General Counsel

Icahn School of Medicine at Mount Sinai

One Gustave L. Levy Place, Box 1099

New York, NY 10029

 

In the case of Miromatrix:

 

Robert Cohen

President & CEO

Miromatrix Medical Inc.

10399 West 70th Street

Eden Prairie, MN 55344

Telephone No: (612) 202-7026

  

		13.	Governing Law. This Agreement shall be governed by and construed in accordance with the
laws of the State of New York exclusive of choice of law. The Parties hereby submit to the exclusive jurisdiction of and venue in any
state or federal courts located within the City of New York, State of New York with respect to any and all disputes concerning the subject
of or otherwise arising under this Agreement.

 

		14.	Entire Agreement. This Agreement, together with all attachments and exhibits, constitutes
the entire agreement and understanding between the parties regarding the subject matter hereof and supersedes any prior or contemporaneous
negotiations, agreements, understandings, or arrangements of any nature or kind with respect to the subject matter herein. In the event
of any inconsistency between this Agreement or any attachments and exhibits, the terms of this Agreement shall govern.

 

     

     

    

 

		15.	Waiver. Neither Party waives its right to enforce any and all provisions of the Agreement
at any time during the Term. Either Party’s failure to enforce any provision shall not prejudice such party from later enforcing
or exercising the same or any other provision of the Agreement.

 

		16.	Modifications. This Agreement may not be changed, altered, modified, amended, rescinded,
canceled or waived except by a writing executed by authorized representatives of the parties.

 

		17.	Binding Agreement on Successors. This Agreement shall be binding upon each party’s
successors and assigns.

 

		18.	Headings. Headings are for convenience of reference only, and not for interpreting the provisions
of the Agreement.

 

		19.	Counterparts. This Agreement may be executed in counterparts, and by either party on separate
counterpart, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

 

 

[the remainder of this page intentionally is
left blank]

 

     

     

    

 

IN WITNESS WHEREOF, the parties
have caused this Agreement to be executed by their respective duly authorized representatives as of the date first above written.

 

	 	MIROMATRIX MEDICAL INC.
	 	 
	 	By:	/s/ Robert Cohen
		Name:	Robert Cohen
		Title:	President & CEO
	 	 	 
		Date:	October 26, 2015
	 	 	 
	 	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
		 	 
	 	By:	/s/ Sybil Lombillo
		Name:	Sybil Lombillo, Ph.D., J.D.
		Title:	Director, Intellectual Property and Asset
                               Development
		 	 
		Date:	Oct 23, 2015
	 	 	 
	 	Principal Investigator confirms that he has read and 

understands this Agreement.
	 	 	 
	 	/s/ Ron Shapiro
	 	Ron Shapiro, MD
	 	 	 
		Date:	Oct 23, 2015

 

     

     

    

  

Exhibit A

Statement of Work

 

The initial development plan for our Transplantable
Kidney Program is divided into two Specific Aims consisting of work being performed both at Miromatrix and at Mount Sinai over a 27 calendar
month period to demonstrate and characterize the first steps involved in creating a transplantable kidney based upon Miromatrix’
perfusion decellularization/recellularization technology by demonstrating continuous blood flow through the transplanted kidney. Miromatrix
will perform all of the work related to Specific Aim #1, building upon our existing progress with our liver and cardiac patch programs,
to provide a re-endothelialized kidney for transplantation and evaluation. Mount Sinai will perform all of the transplantation and characterization
of the transplanted re-vascularized kidney for Specific Aim #2. Miromatrix will provide the re- endothelialized kidney grafts for each
transplant. Below is a summary of the planned actions and desired outcomes of the initial two year program.

 

Summary of Project Specific Aims/Milestones -
2 year program:

 

		A.	GMP Kidney Source, Characterization and Re-Endothelialization [9 months] - MIROMATRIX
	 	 	 

		a.	Optimize kidney decellularization process from porcine sources
	 	 	 

		i.	Aseptic decellularization of whole porcine kidney resulting in a controlled and repeatable process
	 	 	 

		ii.	Define and characterize the appropriately sized kidney
	 	 	 

		b.	Characterize kidney matrix and identify key process
	 	 	 

		i.	Advanced characterization of decellularized kidney including DNA, ECM integrity, vascular integrity, bioburden,
and residual decellularization detergent level
	 	 	 

		c.	Define and implement GMP kidney decellularization process and quality system
	 	 	 

		i.	Definition of release criteria to ensure high level quality control to support all continued development
efforts
	 	 	 

		d.	Complete kidney re-endothelialization with >80% re-endothelialization
	 	 	 

		i.	Determination of the percent reseeding required (5% -75%) for functional revascularization
	 	 	 

		ii.	Definition of non-invasive release criteria

 

		B.	Transplantation of the Re-Endothelialization Kidney and Demonstration of Continuous Blood Perfusion both
Acutely (2 hrs., n=10) and Chronically (10 days, n=10) in a Pig Model [18 months] — MOUNT SINAI
	 	 	 

		a.	Demonstrate continuous blood perfusion through the transplanted re-endothelialized kidney in a pig model
for 2 hrs. (n=10)
	 	 	 

		i.	Perform a nephrectomy to create a suitable transplant location for the re-endothelialized kidney
	 	 	 

		ii.	Surgically transplant the re-endothelialized kidney provided by Miromatrix
	 	 	 

		•	Create the appropriate surgical procedure for the transplantation
	 	 	 

		iii.	Monitor and record blood inflow and outflow during the procedure
	 	 	 

		iv.	Perform Doppler imaging during the transplantation

 

     

     

    

 

		v.	Perform angiogram at the end of the study to characterize vascular patency
	 	 	 

		vi.	Fix and submit explanted kidney for pathology
	 	 	 

		•	Perform standard H&E staining and immunohistochemical staining for endothelial cells
	 	 	 

		b.	Demonstrate continuous blood perfusion in a pig model for 10 days. (n=10)
	 	 	 

		i.	Perform a nephrectomy to create a suitable transplant location for the re-endothelialized kidney
	 	 	 

		ii.	Surgically transplant the re-endothelialized kidney, characterize active perfusion at time of implant,
then close and recover the animal
	 	 	 

		iii.	Perform Doppler imaging at day 1, 3, 5, 8 and 10
	 	 	 

		iv.	Perform perfusion studies at time of explant to characterize inflow and outflow rates on the exposed kidney
	 	 	 

		v.	Explant the kidney and perform angiogram at the end of the study to characterize vascular patency
	 	 	 

		vi.	Fix and submit explanted kidney for pathology
	 	 	 

		•	Perform standard H&E staining and immunohistochemical staining for endothelial cells

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