Study with stem cells from allogenic adipose tissue, in patients with HIV infetion.

Clinical trial Phase I/II, test of concept, double blind, randomized, controlled with placebo, to evalue the safety and efficiency of the treatment with expanded adult mesenchymal stem cells from allogenic adipose tissue, in patients with HIV infection with controlled viral load and immunological discordant response.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000307-26-ES

Enrollment

Registered

2016-02-24

Start date

2016-06-09

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection for HIV with controlled viral load and immunological discordant response MedDRA version: 18.1 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862

Interventions

Product Name: Células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas Product Code: CeTMAd Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV- 1 infection 2. Both sex > 18 years old 3. In antirretrovial treatment 4. HIV viral load 1 year 5. CD4+ value =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation, or refusal to use contraceptive methods with proved efficiency in men and women. 2. Opportunists infections in treatment 3. Active coinfecctions for virus B and C of the hepatitis 4. Stages C of liver cirrosis, according to Child Plugh classification. 5. Portal hypertension and / or hypersplemism of any etiology 6. Presense of malignant neoplasm. 7. Treatment in the last twelve months with steroids, inmunomodulators, interferon, chemotherapy or any treatment that could reverberate in the number of CD4. 8. Any analytical alteration degree 3 or 4 (scale AIDS Clinical Trials Group), confirmed, in the previous blood test taken before the ASC's first infusion.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the safety of the intravenous infusion of 4 doses of allogenic mesenchimal stem cells from adipose tissue (ASC), in patients with infection for HIV and immunological discordant response. 2. To evaluate the efficiency of the intravenous infusion of 4 ASC's doses in the immunological recovery after 3 monthly cycles of CeTMAd's infusion and 1 additional infusion in week 20 in patients with infection for HIV and immunological discordant response. ;Timepoint(s) of evaluation of this end point: 96 weeks; Secondary Objective: To analyze the evolution of the following parameters throughout 1 year after 4 ASC's infusions (1 x 3 monthly infusion plus an additional infusion in week 20) 1. Cellular and soluble markers of AII. 2. Changes on proviral load in PBMCs. 3. To evaluate the relation between the changes in the cell counts of lymphocytes T CD4 + and his % percentages with those observed in the AII markers. ; Primary end point(s): Safety: - Incidence of adverse events grade 3 and 4, "Division of aids table for grading the severity of adult and pediatric adverse events". Publish Date: December, 2004. - Incidence of opportunistic diseases. Efficacy: - Changes in the recount of CD4 + T / ul and CD4 + / CD8 + over 48 weeks.	—

Measure

Time frame

Main Objective: 1. To evaluate the safety of the intravenous infusion of 4 doses of allogenic mesenchimal stem cells from adipose tissue (ASC), in patients with infection for HIV and immunological discordant response. 2. To evaluate the efficiency of the intravenous infusion of 4 ASC's doses in the immunological recovery after 3 monthly cycles of CeTMAd's infusion and 1 additional infusion in week 20 in patients with infection for HIV and immunological discordant response. ;Timepoint(s) of evaluation of this end point: 96 weeks; Secondary Objective: To analyze the evolution of the following parameters throughout 1 year after 4 ASC's infusions (1 x 3 monthly infusion plus an additional infusion in week 20) 1. Cellular and soluble markers of AII. 2. Changes on proviral load in PBMCs. 3. To evaluate the relation between the changes in the cell counts of lymphocytes T CD4 + and his % percentages with those observed in the AII markers. ; Primary end point(s): Safety: - Incidence of adverse events grade 3 and 4, "Division of aids table for grading the severity of adult and pediatric adverse events". Publish Date: December, 2004. - Incidence of opportunistic diseases. Efficacy: - Changes in the recount of CD4 + T / ul and CD4 + / CD8 + over 48 weeks.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 96 weeks; Secondary end point(s): 1. Identification and recount of different cell subpopulations CD4 +, CD8 +, NK and ? ? . 2. Phenotype of different cell subpopulations 3. Soluble mediators. 4. Specific immune response against HIV-1 5. Quantitation of HIV-1 viremia. 6. Quantification of proviral DNA. 7. Microbial translocation.	—

Countries

Spain

Contacts

Public ContactAna Cardesa Gil

Iniciativa Andaluza en Terapias Avanzadas-Fundación Pública Andaluza Progreso y Salud

ana.cardesa@juntadeandalucia.es+34NA955048366NA

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026