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This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.
This Individual Patient Expanded Access IND has been created per the request of a 65-year-old woman diagnosed with Systemic Lupus Erythematosus (SLE).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-adMSCs | Biological | Subject has completed 10 infusions and has been authorized for an additional 12 infusions over 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thanh Cheng, MD | Hope Biosciences Stem Cell Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Biosciences Stem Cell Research Foundation | Sugar Land | Texas | 77478 | United States |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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