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Infusion of MSC

Phase 1

Discordant Immunological Response in HIV Infected Subjects | Small molecule | Infectious Disease |Design Therapeutics, Inc.|Last Updated: Mar 4, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

Infusion of MSC · 1 trial · 1 indication

Phase 1 1
NCT02290041Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant ResponseDiscordant Immunological Response in HIV Infected Subjects
COMPLETED5 Analytics
PHASE1COMPLETED
Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
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Study Endpoints

Primary Endpoints

Incidence of adverse reactions
24 months

Incidence of adverse reactions grade 3 and 4 according to DAIDs scale

Incidence of opportunist diseases
24 months
Changes in CD4+ cell count and CD4+/CD8+ ratio
28 days after the 4th infusion MSCs/placebo

Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry

Secondary Endpoints

T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks
48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mesenchymal stem cellsEXPERIMENTALIntravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue
PlaceboPLACEBO_COMPARATORIntravenous infusion of 4 doses of Placebo

Interventions

NameTypeDescription
Infusion of MSCDRUGIntravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20).
Infusion of placeboDRUGInfusion of placebo (weeks 0-4-8-20)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Confirmed HIV infection * Age\> 18 years, both sexes * In treatment with antiretroviral therapy (ART) * Sustained HIV viral load \<50 copies / ml for ≥ 1 years prior to study entry * CD4 + cell count \< 350/mL * Immunological discordant response defined as: an increase \<75 or...

Countries:Spain
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Frequently asked questions about Infusion of MSC

What is Infusion of MSC used for in Discordant Immunological Response in HIV Infected Subjects?

Infusion of MSC is an investigational small molecule being studied for the treatment of Discordant Immunological Response in HIV Infected Subjects. It is being developed by Design Therapeutics, Inc. (NASDAQ: DSGN) and is currently in Phase 1 clinical development.

Who makes Infusion of MSC?

Infusion of MSC is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker DSGN. The drug is in Phase 1 clinical development for Discordant Immunological Response in HIV Infected Subjects.

What phase is Infusion of MSC in?

Infusion of MSC is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial for this drug has been completed.

What clinical trials is Infusion of MSC in?

Infusion of MSC has one completed clinical trial, NCT02290041, titled "Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response." This Phase 1 trial enrolled 5 participants in Spain and was placebo-controlled, randomized, and double-blind.

Is Infusion of MSC the same as MSC?

Infusion of MSC is the drug name used in the clinical trial NCT02290041. The trial title refers to treatment with MSC in HIV-infected patients. The drug is being developed by Design Therapeutics, Inc. for Discordant Immunological Response in HIV Infected Subjects.