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Inflammatory Biosignatures for the Identification of Sickle Cell Associated Pain Phenotypes (IBIS-CAP)

Award Number: R01HL183340
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/25/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2031

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Inflammatory Biosignatures for the Identification of Sickle Cell Associated Pain Phenotypes (IBIS-CAP) - Project Summary: SCD is characterized by a globin mutation that leads to hemolysis, vaso-occlusion, progressive organ injury, pain and death. Despite recent advances chronic pain remains a major cause of suffering and morbidity, with poorly understood biology and no targeted treatments. Previous attempts to generate biomarkers for chronic SCD pain failed, likely because chronic pain is not homogenous, with underlying pathophysiology too complex to be measured with a single biomarker. Our group, with expertise in chronic pain pathophysiology, clinical trials design, and proteomic and genomic network modelling, generated preliminary proteomic signatures, composed of multiple biomarkers, for the three main types of SCD chronic pain: nociceptive (due to tissue damage and inflammation), neuropathic (pain due to damage to the central and/or peripheral nervous system) and nociplastic (due to peripheral and/or central sensitization). These signatures were able to effectively distinguish between different types of SCD chronic pain with a single measurement. Our global hypothesis is that chronic pain in SCD is heterogenous and that each pain phenotype can be identified using combinations of biomarkers to form proteomic signatures. Further, we hypothesize that by examining repeated measures of these signatures over time and including genomic data we can perform a network analysis to determine drivers of chronic pain phenotypes. We also performed a small double blinded randomized study where patients with SCD and chronic pain were given dronabinol or placebo for 8 weeks and demonstrated those who received dronabinol had reduced markers of mast cell activation and improvement in clinical symptoms, though response was stronger in some patients than others. We believe this may serve as proof of concept that targeting pathways involved in the signature of each pain type may be effective treatment, especially for those with chronic pain of that phenotype. To test these hypotheses, we will complete the following aims: Aim 1: To characterize the proteomic signatures of pain phenotypes in people with SCD. Aim 2: To determine the effect of dronabinol on chronic pain, and chronic pain subtypes in SCD. Aim 3: Elucidate candidate mechanisms and potential therapeutic targets underlying pain phenotypes. We will enroll patients at Icahn School of Medicine at Mount Sinai and Emory University, two of the largest SCD centers in the United States, into a double-blind placebo-controlled study of 6 months of dronabinol or placebo. Patients will have proteomic panels drawn at baseline and multiple time points during the study, we will use these to generate proteomic signatures for each pain type. We will use this data to design a phase III study of dronabinol to further explore the mechanistic hypothesis that to treat chronic pain in SCD it is necessary to target the underlying mechanisms of the pain phenotype present. This project is the culmination of K23 funded work by Dr. Susanna Curtis, an early stage investigator and Assistant Director of the Mount Sinai Center for SCD with over 2000 patients and over $25 million in total NIH funding.


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 = $834,899 )
2026	2026	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Blood Diseases and Resources Research	000	1	8/27/2026	NEW	$834,899
														Subtotal = $834,899

Grand Total All Awards = $834,899

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Inflammatory Biosignatures for the Identification of Sickle Cell Associated Pain Phenotypes (IBIS-CAP)

Award Number: R01HL183340

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/25/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2031

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