Stem Cell Educator Therapy in Alopecia Areata
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|ClinicalTrials.gov Identifier: NCT01673789|
Recruitment Status : Unknown
Verified August 2012 by Tianhe Stem Cell Biotechnologies Inc..
Recruitment status was: Recruiting
First Posted : August 28, 2012
Last Update Posted : August 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alopecia Areata||Device: Stem Cell Educator||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/Phase 2 Study of Stem Cell Educator Therapy in Alopecia Areata|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
Experimental: Stem Cell Educator
The collected lymphocytes are transferred into the device for exposure to CB-SCs, and other blood components are automatically returned to the patient. The Stem Cell Educator functions as part of a closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with CB-SCs in vitro, and returns the educated lymphocytes to the patient's circulation. CB-SCs tightly attached to interior surfaces in the device, and only the CB-SC-educated autologous lymphocytes are returned to the subjects. The Stem Cell Educator therapy requires only two venipunctures with minimal pain, and does not introduce stem cells or reagents into patients.
Device: Stem Cell Educator
For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 8 ~ 9 hrs.
- Feasibility and efficacy of Stem Cell Educator therapy in AA [ Time Frame: 1 year ]The primary study end points are 1) feasibility of the Stem Cell Educator therapy in AA, 2) preliminary evaluation of the efficacy of the therapy for improving hire grow through a year.
- The efficacy of Stem Cell Educator therapy in modulating autoimmunity [ Time Frame: 1 year ]The secondary study end point was evidence of the efficacy of the therapy in modulating autoimmunity. Baseline blood samples are collected prior to Stem Cell Educator therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673789
|The First Hospital of Hebei Medical University||Recruiting|
|Shijiazhuang, Hebei, China, 050031|
|Contact: Yanjia Li, MD 86 311 85917311 firstname.lastname@example.org|
|Sub-Investigator: Yanjia Li, MD|
|Study Chair:||Yong Zhao, MD, PhD||Tianhe Stem Cell Biotechnologies Inc.|