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Enriched Hematopoetic Stem Cell Infusion

Phase 1

Sickle Cell Disease | Monoclonal antibody | Hematology |Tourmaline Bio, Inc.|Last Updated: Oct 14, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

Enriched Hematopoetic Stem Cell Infusion · 1 trial · 1 indication

Phase 1 1
NCT00777231Phase I/II Pilot Study of Mixed Chimerism to Treat HemoglobinopathiesSickle Cell Disease
COMPLETED9 Analytics
PHASE1COMPLETED
Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies
Sickle Cell DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Level of Donor Chimerism from Enriched Hematopoietic Stem Cell Engraftment
From one month to three years

Tests are done at key time points to monitor for donor chimerism by evaluating presence of bone marrow-derived hematopoietic stem cells.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sickle Cell DiseaseEXPERIMENTALRecipients treated with an enriched hematopoetic stem cell infusion
Non-Malignant DisordersEXPERIMENTALRecipients treated with an enriched hematopoetic stem cell infusion
Aplastic AnemiaEXPERIMENTALRecipients treated with an enriched hematopoetic stem cell infusion
Sickle Cell Disease : Extended ProtocolEXPERIMENTALRecipients treated with an enriched hematopoetic stem cell infusion and Campath 1H conditioning

Interventions

NameTypeDescription
Enriched Hematopoetic Stem Cell InfusionBIOLOGICALEnriched Hematopoetic Stem Cell Infusion
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: The following criteria are established to identify subjects with sickle cell disease (SCD) who have a high predicted morbidity and are at risk for early mortality. Subjects with S/S disease, S/C disease, Hemoglobin H disease, Alpha Thalassemia Major, Thalassemia Major (also know...

Countries:United States
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Frequently asked questions about Enriched Hematopoetic Stem Cell Infusion

What is Enriched Hematopoetic Stem Cell Infusion used for in Sickle Cell Disease?

Enriched Hematopoetic Stem Cell Infusion is an investigational therapy being studied for Sickle Cell Disease. It is a monoclonal antibody-based approach that involves infusing enriched hematopoietic stem cells. The therapy is currently in Phase 1 clinical development, with one completed trial that enrolled 9 participants.

What does Enriched Hematopoetic Stem Cell Infusion target?

Enriched Hematopoetic Stem Cell Infusion is a monoclonal antibody therapy, but its specific molecular target has not been disclosed. The therapy is being investigated for its potential to treat Sickle Cell Disease by infusing enriched hematopoietic stem cells, though the exact mechanism of action is not publicly detailed.

Who makes Enriched Hematopoetic Stem Cell Infusion?

Enriched Hematopoetic Stem Cell Infusion is being developed by Tourmaline Bio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TRML. The company is conducting clinical research on this therapy for Sickle Cell Disease, with the therapy currently in Phase 1 development.

What phase is Enriched Hematopoetic Stem Cell Infusion in?

Enriched Hematopoetic Stem Cell Infusion is in Phase 1 clinical development. It is an investigational therapy for Sickle Cell Disease and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 9 participants, and the therapy remains under investigation.

What clinical trials is Enriched Hematopoetic Stem Cell Infusion in?

Enriched Hematopoetic Stem Cell Infusion has been studied in one clinical trial, identified as NCT00777231, titled 'Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies.' This Phase 1 trial, conducted in the United States, enrolled 9 participants with Sickle Cell Disease and has been completed.