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Umbilical Cord Mesenchymal Stem Cells for Immune Reconstitution in HIV-infected Patients

NCT01213186 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-05-29

No results posted yet for this study

Summary

HIV-1 infection is characterized by progressive depletion of CD4+ T cells that eventually leads to clinically significant immunodeficiency. A chronic generalized immune activation is now being recognized to be the main driving force for T cell depletion, loss of anti-HIV-1 immunity and disease progression during chronic HIV-1 infection. However, it is still unknown whether reducing immune activation will restore CD4 T cell counts and leading to immune reconstitution in chronic HIV infection. Mesenchymal stem cells (MSC) have been demonstrated to decrease immune responses of the host, and can suppress inflammation in HIV-infected non-responders. Here, the investigators propose a hypothesis that MSC can reduce immune activation which subsequently lead to the restoration of CD4 T-cell counts dependent on dose of transfused MSCs in HIV-infected patients.

Conditions

  • Human Immunodeficiency Virus
  • Disorder of Immune Reconstitution

Interventions

DRUG

high dose of MSC

Taken i.v., at week 0, 4, 12, 24, 36 and 48, at a dose of 1.5\*10E6/kg for 48 weeks.

DRUG

low dose of MSC treatment

Taken i.v., at week 0, 4, 12, 24, 36 and 48, at a dose of 0.5\*10E6/kg for 48 weeks.

Sponsors & Collaborators

  • Fu-Sheng Wang

    lead OTHER

Principal Investigators

  • Fu-Sheng Wang, Professor · Beijing 302 Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213186 on ClinicalTrials.gov