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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Immune System Diseases [C20]; 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

• Registration Number: EUCTR2014-000307-26-ES
• Lead Sponsor: Iniciativa Andaluza en Terapias Avanzadas-Fundación Pública Andaluza Progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-24
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1.HIV- 1 infection
2.Both sex > 18 years old
3.In antirretrovial treatment
4.HIV viral load < 50 copies/ml during > 1 year
5.CD4+ value < 350/?l
6.Immunological discordant response (IDR) defined as:
- increase <75 or <150 CD4 + / µl after one or two years of undetectable viral load, respectively with the basal situation
, or
- recount of CD4 + <350/?l after 3 years of anti-retroviral treatment and undetectable viral load (<50 copias/ml) ? 1 year.
7.Writen inform consent form from the patients.
8.Commitment to use a contraceptive method with proved efficiency in men and women during the duration of the clinical trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified