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Mechanisms of placental mimicry cell therapy

Award Number: R01AI193128
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/13/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2031

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Mechanisms of placental mimicry cell therapy - SUMMARY Cell therapies are a promising alternative therapy for the treatment of type 1 diabetes, and stem cell-derived insulin secreting beta cells (sBC) have demonstrated the feasibility of restoring insulin independence in clinical models. However, this strategy has limited long-term application due to the requirement of ineffective and toxic immunosuppressive drug regimens and immune rejection, which currently limits the applicable patient pool to high-risk patients. The leading commercial entities clinically testing stem cell-derived islet replacement products are pursuing macroencapsulated cell delivery methods to overcome this critical hurdle to translation. Macroencapsulation devices can blunt immune responses to the graft and confer the safety benefit of cell delivery in a single, retrievable device. However, functional clinical success of these devices has not been demonstrated to date due in part to inevitable antigen shedding resulting in indirect antigen recognition, which results in immune destruction of encapsulated cells. Thus, synergistic immunomodulatory approaches are necessary to fully immunoprotect encapsulated cell grafts, and achieve immunological tolerance in the absence of immune suppression. The fetal-maternal interface is a robust model of immune tolerance toward allogeneic tissue, where placental trophoblasts maintain tolerance by two main approaches: (1) presenting an inert surface to maternal immune cells, a strategy akin to cell encapsulation which blocks direct antigen recognition; and (2) through secretion of tolerogenic factors which induce tolerance toward fetal antigens that escape the placenta. Our preliminary data demonstrates that a macroencapsulated tolerogenic trophoblast cell therapy can evade rejection and delay rejection of bystander macroencapsulated cell grafts in a challenging xenotransplant model. In this proposal, we aim to (1) validate our preliminary studies using translatable cell sources of sBC and trophoblasts, and (2) elucidate the immunological mechanisms of trophoblast cell therapy-induced tolerance in xeno and humanized allogeneic transplantation models. This will be addressed in three Specific Aims: (1) Identify immune mechanisms of trophoblast cell therapy-induced transplant site-dependent graft tolerance, (2) Optimize and characterize tolerogenic cell therapy dose impact on tolerance induction, and (3) Untangle the contributions of antigen-specific and non-specific mechanisms of trophoblast cell therapy tolerance induction. In this work, we expect to identify the immunological mechanisms by which tolerogenic trophoblast cell therapies delay or prevent immune rejection.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $742,634 )
2026	2026	ARIZONA STATE UNIVERSITY	1475 N SCOTTSDALE RD STE 200	SCOTTSDALE	AZ	85257	MARICOPA	USA	Allergy and Infectious Diseases Research	000	1	5/13/2026	NEW	$742,634
														Subtotal = $742,634

Grand Total All Awards = $742,634

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Mechanisms of placental mimicry cell therapy

Award Number: R01AI193128

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/13/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2031

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