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A Tissue Support Structure (Macular O-Rings) for Reconstructing, Translocating or Transplanting Three-Dimensional Submacular Tissue Organoids in Age Related Macular Degeneration (AMD)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EY028803-01A1
Agency Tracking Number: R41EY028803
Amount: $289,064.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NEI
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-01
Award End Date (Contract End Date): 2021-02-28
Small Business Information
1081 SPRINGDALE RD NE, Atlanta, GA, 30306-2653
DUNS: 080591835
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 TERENCE WALTS
 (404) 371-9834
 tawalts@yahoo.com
Business Contact
 TIMOTHY OLSEN
Phone: (404) 290-6418
Email: twolsen010@gmail.com
Research Institution
 MAYO CLINIC ROCHESTER
 200 1ST ST SW
ROCHESTER, MN, 55905-0001
 Domestic nonprofit research organization
Abstract
Project Summary Abstract Age related macular degenerationAMDis a leading form of irreversible blindnessiMacular Regeneration LLCiMac Regenwill introduce a novel tissue support structuremacular O rings or MORsmade from a biocompatibleimplantable materialnitinol or nickel titanium alloyThe surgical deviceMORwill be tested both ex vivo and in vivo for proof of concept in this phase I STTR studyThe device will support and protect donor tissuereconstruct the degenerating tissue in the submacular spaceenable translocation of autographsand or potentially other transplants or three dimensional tissue organoids into the submacular spaceThis surgical device represents a critical unmet need in the current approach for regenerative medicine that addresses macular diseaseCurrentlymany researchers are attempting to replace a portion of the damaged supporting tissuesFor examplesome investigators are injecting dissociated retinal pigment epitheliumRPEor sheets of RPE monolayers alone or grown on synthetic substratessome from embryonic or adult progenitor stem cellsAttempts to inject free floating stem cells directly into the subretinal space to replace or support existing RPE have been attempted with limited successThe iMac Regen approach is unique and serves as a platform technology for many forms of tissue or cellular transplantation into the submacular spaceMORs provide a biocompatible perimeter scaffoldmuch like a frame to support a paintingThusthe MORs facilitate surgical manipulation and minimize tissue injury for the delicatethree dimensionalchoroid Bruchandapos s RPECBRtissue transplants used in translocation surgeryOur current proposal is to test a new GMPgood manufacturing processesdevice ex vivo and ensure proper donor tissue engagementThenwe will translocate an autologous grafta graft harvested from the same eyein the live pig modelThe autologous graft eliminates the risk of immune mediated graft rejectionUsing this regenerative medicine approachthe goal is to rescue damaged macular photoreceptorsMPRsand restore their function before MPRs are permanently lost to advanced forms of AMDThis novel surgical device is proposed for those at or near the end stages of dry or wet AMD as well as other forms of macular degenerationThe three dimensional CBR graft represents an organoid that has all of the necessary cellularmembraneand vascular components to provide the necessary blood flownutritionaland visual cycle support required by the MPRsStudies from Europe have shown that transplant healthy CBR auto graft tissue in humans inhibits abnormal angiogenesis wet AMDThe circumferential configurationframeof our device allows for tissue support without directly interfering with blood flow to the critical central region of the tissue graftLoss of function in AMD results from damaged CBR tissue and occurs at the end stages of both the wet and dry forms of AMDthus leading to MPR death and blindnessThe MORs are made from nitinola biocompatiblenon magneticimplantable structure that has identical material as that used for decades for intra arterialcoronary artery stentsThe MORs serveas a structural support for CBR donor graftto enable surgical manipulation of a delicate CBR graftandminimize CBR tissue shrinkage and injuryWe predict that the result of our work will be regeneration of dying MPRs and inhibition of choroidal angiogenesisMilestones includedemonstration of the ability of the GMP device to attach and support donor tissuebiocompatibility of nitinol in the subretinal spacewith limited fibrosisin vivo donor CBR tissue engraftment with vascularizationfunctional results using electrophysiologyandhistologic verification in conjunction with two ophthalmic pathologists at the Mayo Clinic forabiocompatibilitybgraft vascularizationctissue reactionscarringand dviable overlying MPRsWe are working toward commercialization through a feasibility process with supporting proof of concept for the newly manufactured GMP deviceplus derivative instrumentsin phase I STTRWe anticipate some minor device modifications based on these studiesRequired IDEInvestigational Device Exemptionquality data in preparation for an audit will be acquired as we proceed along aK regulatory pathway and into phase II of the STTR funding mechanism Narrative We will test a novel surgical device that represents a platform technology to transplant donor tissue grafts that support macular functionreplace damaged submacular tissuesregenerate macular photoreceptors and inhibit abnormal choroidal angiogenesisThis technology will address a critical unmet need in the treatment of advanced age related macular degenerationa leadingworldwide cause of irreversible blindness

* Information listed above is at the time of submission. *

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