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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud.
Recruitment status was:  Not yet recruiting
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT02290041
First received: November 10, 2014
Last updated: June 12, 2015
Last verified: November 2014
  Purpose
Clinical trial phase I/II, of test of concept, blind double, and controlled with placebo, randomized 2:1 (Treatment: placebo), in which a total of 15 patients will be included

Condition Intervention Phase
HIV
Drug: Infusion of MSC
Drug: Infusion of placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Incidence of adverse reactions [ Time Frame: 24 months ]
    Incidence of Grade 3 and 4 adverse reactions, including the alteration of a laboratory parameter, using the scale "Division of aids table for grading the severity of adult and paediatric adverse Events". Publish Date: December, 2004

  • Incidence of opportunist diseases [ Time Frame: 24 months ]

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

Estimated Enrollment: 15
Study Start Date: March 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 allogenic adult mesenchymal stem cells from adipose tissue
Placebo Comparator: Placebo
Intravenous infusion of 4 doses of Placebo
Drug: Infusion of placebo
Infusion of placebo
Other Name: Placebo

Detailed Description:
Clinical trial phase I/II, of test of concept, blind double, controlled with placebo, randomized, in which a total of 15 patients will be included In an initial phase, there will be included 5 patients of sequential form, with a minimum of 15 days of safety period between the first infusion of a patient and the first one of the following patient. These first 5 patients will not be randomized, being all of them treated with the medicine in investigation. When the last one of these 5 patients has received the first three foreseen doses, the safety information will be evaluated by an Independent Data Monitoring Committee. If this evaluation is positive, it will be continued by the trial being recruited the rest of patients (n = 10). After randomization, 5 of these patients will receive cellular therapy and the other 5 will receive an infusion of the placebo product.
  Eligibility

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

Inclusion Criteria:

  • Age> 18 years. Both sexes
  • In antiretroviral therapy for HIV Infection
  • HIV Viral load <50 copies / ml during >1 year
  • Value of CD4 + <350/mcl
  • Immunological discordant response defined as an increase <75 or <150 in CD4+ cell counts after one or two years of undetectable viraemia, respectively, with regard to the basal determination or as an recount of CD4 + <350/mcl after 3 years of anti-retroviral treatment and undetectable viraemia (<50 copies/ml) ≥ 1 year
  • Writing informed consent
  • Commitment of utilization of a contraceptive method of proved efficiency in both men and women during the duration of the clinical trial

Exclusion Criteria:

  • Pregnancy, lactation, or denial to the use of contraceptive methods of proved efficiency in both men and women
  • Opportunistic infections with ongoing treatment
  • Hepatitis B virus/hepatitis C virus coinfection
  • Hepatic cirrhosis stadium C of Child Pugh's classification of any a aetiology
  • Portal hypertension and / or hypersplenism of any aetiology
  • Presence malignant neoplasia
  • Treatment with steroids, immunomodulator, interferon, chemotherapy or any medicinal product that could reverberate in the number of CD4 in the last twelve months
  • Any analytical alteration 3 or 4 grade (AIDS Clinical Trials Group scale), confirmed, in the analytical prior to the first infusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02290041

Contacts
Contact: Luis F. López Cortés, MD 955013096 lflopez@us.es
Contact: Ana Cardesa Gil 955048366 ana.cardesa@juntadeandalucia.es

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

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
Study First Received: November 10, 2014
Last Updated: June 12, 2015

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
mesenchymal stem cells
Virus of human immunodeficiency Infection

Additional relevant MeSH terms:
Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on March 24, 2017