Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
- Conditions
- Discordant Immunological Response in HIV Infected Subjects
- Interventions
- Drug: Infusion of placeboDrug: Infusion of MSC
- Registration Number
- NCT02290041
- Lead Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Brief Summary
Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects
- Detailed Description
This is a phase I-II, randomised, placebo-controlled, clinical trial, currently ongoing in a single Spanish hospital (Hospital Virgen del Rocío, Seville), to evaluate the safety and feasibility of a 4-doses treatment regimen with MSCs (1 million cells/Kg MSCs, weeks 0-4-8-20) in HIV infected adults with swith discordant virological and immunological response to antiretroviral therapy. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 15 days, receiving unblinded cell therapy. In the second phase of the trial, subjects are block randomised (1:1) to receive either MSCs (n=5), or placebo (n=5), as the control treatment. Immune response variables, adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 24 months, that includes 17 visits according to a decreasing frequency rate. Intention to treat, and per protocol, and safety analysis will be performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Infusion of placebo Intravenous infusion of 4 doses of Placebo Mesenchymal stem cells Infusion of MSC Intravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks 48 weeks
Trial Locations
- Locations (1)
Virgen del Rocío University Hospital
🇪🇸Seville, Spain