Status:
UNKNOWN
Umbilical Cord Mesenchymal Stem Cells for Immune Reconstitution in HIV-infected Patients
Lead Sponsor:
Fu-Sheng Wang
Conditions:
Human Immunodeficiency Virus
Disorder of Immune Reconstitution
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 recogni...
Detailed Description
Although 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 bein...
Eligibility Criteria
Inclusion
- HIV infected
- antiretroviral therapy (ART) for at least 24 months prior to study entry and continue within the 24 months after study entry
- 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
- Viral load less than or equal to 50 copies/mL obtained within 30 days prior to study entry
- Certain specified laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the study protocol.
- Documentation that pre-entry specimen for the primary immune activation endpoint responses has been obtained
- No history of CDC category C AIDS-related opportunistic infections
- Karnofsky performance score greater than or equal to 70 within 30 days prior to study entry
- Ability and willingness to provide informed consent
Exclusion
- 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.
- history of combination with other severe diseases including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors.
- WBC \<2.5\*10E9/L, platlet counts \<50\*10E9/L, Hb \<80g/L, lactate \>2 mmol/L;
- allergic constitution;
- Accepting other immunomodulatory drugs within 6 months prior screening.
- drug addiction;
- other conditions possibly influencing the trial.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01213186
Start Date
January 1 2013
End Date
June 1 2016
Last Update
May 29 2013
Active Locations (3)
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1
Beijing 302 Hospital
Beijing, Beijing Municipality, China, 100039
2
Xinjiang Hospital of Infectious Diseases
Ürümqi, Xinjiang, China, 830013
3
the Yunnan Hospital of Infectious Diseases
Kunming, Yunnan, China, 650301