NCT02290041

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2.2 years until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

November 10, 2014

Last Update Submit

March 3, 2020

Conditions

Discordant Immunological Response in HIV Infected Subjects

Keywords

mesenchymal stem cellsHIV Infectiondiscordant immunological response

Outcome Measures

Primary Outcomes (3)

  • Incidence of adverse reactions

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

    24 months

  • Incidence of opportunist diseases

    24 months

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

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

    28 days after the 4th infusion MSCs/placebo

Secondary Outcomes (1)

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

    48 weeks

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

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

Drug: Infusion of MSC

Placebo

PLACEBO COMPARATOR

Intravenous infusion of 4 doses of Placebo

Drug: Infusion of placebo

Interventions

Infusion of MSCDRUG

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

Mesenchymal stem cells
Infusion of placeboDRUG

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

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virgen del Rocío University Hospital

Seville, 41013, Spain

Location

Related Publications (1)

  • 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.

    PMID: 33264515DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Luis F. López Cortés, MD

    Hospitales Universitarios Virgen del Rocío

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase 1: uncontrolled, single arm biosafety evaluation (n=5) Phase 2: placebo-controlled, randomized, evaluation (n=10)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 13, 2014

Study Start

February 8, 2017

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

ES(1)