Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response

• Status: Completed
• Trial end date: 2019-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborator: Iniciativa Andaluza en Terapias Avanzadas

Criteria

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 <150 in CD4+ cell counts within one or two years of undetectable viraemia, respectively; or CD4 + cell count <350/mcl after 3 years of ART and undetectable viraemia (<50 copies/ml) ≥ 1 year

• Writen informed consent

• In women of child bearing potential or her partners:commitment to use contraceptive method of proved efficiency throughout the duration of the clinical trial

Exclusion Criteria:

• Pregnancy, breastfeeding, or refusal to the use of contraceptive methods

• Opportunistic infections in the last 12 months prior to study entry

• Active co-infection with hepatitis B virus/hepatitis C virus

• Child Pugh's scale stage C cirrhosis of the liver of any a aetiology

• Portal hypertension and / or hypersplenism of any aetiology

• Malignant neoplasia

• Treatment with steroids, immunomodulators, interferon, chemotherapy or any other medicinal product that could modify the number of CD4+ within the last 12 months prior to study entry

• Confirmed analytical 3 or 4 grade (AIDS Clinical Trials Group scale) abnormalities