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
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
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Seville, Spain, 41013
- Virgen del Rocio University Hospital
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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 |
|---|---|
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Experimental: Mesenchymal stem cells
Intravenous infusion of 4 doses of allogenic adult mesenchymal stem cells from adipose tissue
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Intravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20).
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Placebo Comparator: Placebo
Intravenous infusion of 4 doses of Placebo
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Infusion of placebo (weeks 0-4-8-20)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of adverse reactions
Time Frame: 24 months
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Incidence of adverse reactions grade 3 and 4 according to DAIDs scale
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24 months
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Incidence of opportunist diseases
Time Frame: 24 months
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24 months
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Changes in CD4+ cell count and CD4+/CD8+ ratio
Time Frame: 28 days after the 4th infusion MSCs/placebo
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Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry
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28 days after the 4th infusion MSCs/placebo
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks
Time Frame: 48 weeks
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48 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
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
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
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