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

Primary Purpose

Discordant Immunological Response in HIV Infected Subjects

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Infusion of MSC

Infusion of placebo

About this trial

This is an interventional treatment trial for Discordant Immunological Response in HIV Infected Subjects focused on measuring mesenchymal stem cells, HIV Infection, discordant immunological response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Virgen del Rocío University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesenchymal stem cells

Placebo

Arm Description

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

Intravenous infusion of 4 doses of Placebo

Outcomes

Primary Outcome Measures

Incidence of adverse reactions

Incidence of adverse reactions grade 3 and 4 according to DAIDs scale

Incidence of opportunist diseases

Changes in CD4+ cell count and CD4+/CD8+ ratio

Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry

Secondary Outcome Measures

T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks

Full Information

NCT ID

NCT02290041

First Posted

November 10, 2014

Last Updated

March 3, 2020

Sponsor

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

Collaborators

Iniciativa Andaluza en Terapias Avanzadas

1. Study Identification

Unique Protocol Identification Number

NCT02290041

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

February 8, 2017 (Actual)

Primary Completion Date

July 30, 2019 (Actual)

Study Completion Date

July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Iniciativa Andaluza en Terapias Avanzadas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Discordant Immunological Response in HIV Infected Subjects

Keywords

mesenchymal stem cells, HIV Infection, discordant immunological response

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mesenchymal stem cells

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intravenous infusion of 4 doses of Placebo

Intervention Type

Drug

Intervention Name(s)

Infusion of MSC

Intervention Description

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

Intervention Name(s)

Infusion of placebo

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse reactions

Description

Incidence of adverse reactions grade 3 and 4 according to DAIDs scale

Time Frame

24 months

Title

Incidence of opportunist diseases

Time Frame

24 months

Title

Changes in CD4+ cell count and CD4+/CD8+ ratio

Description

Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry

Time Frame

28 days after the 4th infusion MSCs/placebo

Secondary Outcome Measure Information:

Title

T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis F. López Cortés, MD

Organizational Affiliation

Hospitales Universitarios Virgen del Rocío

Official's Role

Study Chair

Facility Information:

Facility Name

Virgen del Rocío University Hospital

City

Seville

ZIP/Postal Code

41013

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

33264515

Citation

Trujillo-Rodriguez M, Viciana P, Rivas-Jeremias I, Alvarez-Rios AI, Ruiz-Garcia A, Espinosa-Ibanez O, Arias-Santiago S, Martinez-Atienza J, Mata R, Fernandez-Lopez O, Ruiz-Mateos E, Gutierrez-Valencia A, Lopez-Cortes LF. Mesenchymal stromal cells in human immunodeficiency virus-infected patients with discordant immune response: Early results of a phase I/II clinical trial. Stem Cells Transl Med. 2021 Apr;10(4):534-541. doi: 10.1002/sctm.20-0213. Epub 2020 Dec 2.

Results Reference

derived

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

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