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

March 3, 2020 updated by: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Clinical Trial Phase I/II, of Test of Concept, Blind Double, Randomized, Controlled With Placebo, to Assess the Safety and Efficiency of the Treatment With Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue Expanded, in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Virgen del Rocío University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal stem cells
Intravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue
Drug: 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).
Placebo Comparator: Placebo
Intravenous infusion of 4 doses of Placebo
Drug: Infusion of placebo
Infusion of placebo (weeks 0-4-8-20)
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse reactions
Time Frame: 24 months
Incidence of adverse reactions grade 3 and 4 according to DAIDs scale
24 months
Incidence of opportunist diseases
Time Frame: 24 months
24 months
Changes in CD4+ cell count and CD4+/CD8+ ratio
Time Frame: 28 days after the 4th infusion MSCs/placebo
Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry
28 days after the 4th infusion MSCs/placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Collaborators

Iniciativa Andaluza en Terapias Avanzadas

Investigators

  • Study Chair: Luis F. López Cortés, MD, Hospitales Universitarios Virgen del Rocío

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2017

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CeTMAd-VIH-2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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