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

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ClinicalTrials.gov Identifier: NCT02290041
Recruitment Status : Active, not recruiting
First Posted : November 13, 2014
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Discordant Immunological Response in HIV Infected Subjects Drug: Infusion of MSC Drug: Infusion of placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1: uncontrolled, single arm biosafety evaluation (n=5) Phase 2: placebo-controlled, randomized, evaluation (n=10)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: Placebo




Primary Outcome Measures :
  1. Incidence of adverse reactions [ Time Frame: 24 months ]
    Incidence of adverse reactions grade 3 and 4 according to DAIDs scale

  2. Incidence of opportunist diseases [ Time Frame: 24 months ]
  3. 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


Secondary Outcome Measures :
  1. T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290041


Locations
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Spain
Virgen del Rocío University Hospital
Seville, Spain, 41013
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas
Investigators
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Study Chair: Luis F. López Cortés, MD Hospitales Universitarios Virgen del Rocío

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Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02290041     History of Changes
Other Study ID Numbers: CeTMAd-VIH-2014
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
mesenchymal stem cells
HIV Infection
discordant immunological response
Additional relevant MeSH terms:
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Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes