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

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fu-Sheng Wang

Criteria

Inclusion Criteria:

1. HIV infected

2. antiretroviral therapy (ART) for at least 24 months prior to study entry and continue within the 24 months after study entry

3. CD4 count less than or equal to 250 cells/mm3 continuously and more than 50 cells/mm3 before entry and at screening, obtained within 30 days prior to study entry

4. Viral load less than or equal to 50 copies/mL obtained within 30 days prior to study entry

5. Certain specified laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the study protocol.

6. Documentation that pre-entry specimen for the primary immune activation endpoint responses has been obtained

7. No history of CDC category C AIDS-related opportunistic infections

8. Karnofsky performance score greater than or equal to 70 within 30 days prior to study entry

9. Ability and willingness to provide informed consent

Exclusion Criteria:

1. coinfection with other virus, including serum HCV RNA positive, or one of followings are positive in antiHAV/anti-HDV/anti-HEV plus ALT more than 80 IU/L.

2. history of combination with other severe diseases including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors.

3. WBC <2.5*10E9/L, platlet counts <50*10E9/L, Hb <80g/L, lactate >2 mmol/L;

4. allergic constitution;

5. Accepting other immunomodulatory drugs within 6 months prior screening.

6. drug addiction;

7. other conditions possibly influencing the trial.