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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-08

Study Completion Date

2019-07-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Discordant Immunological Response in HIV Infected Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 1: uncontrolled, single arm biosafety evaluation (n=5) Phase 2: placebo-controlled, randomized, evaluation (n=10)

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mesenchymal stem cells

Intravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue

Group Type EXPERIMENTAL

Infusion of MSC

Intervention Type DRUG

Intravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20).

Placebo

Intravenous infusion of 4 doses of Placebo

Group Type PLACEBO_COMPARATOR

Infusion of placebo

Intervention Type DRUG

Infusion of placebo (weeks 0-4-8-20)

Interventions

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Infusion of MSC

Intravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20).

Intervention Type DRUG

Infusion of placebo

Infusion of placebo (weeks 0-4-8-20)

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No