HBCMD01- Expanded Access for the Treatment of Congenital Muscular Dystrophy.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05154851|
Expanded Access Status : No longer available
First Posted : December 13, 2021
Last Update Posted : August 1, 2022
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|Condition or disease||Intervention/treatment|
|Congenital Muscular Dystrophy Due to Lamin A/C Mutation||Biological: HB-adMSCs|
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|Official Title:||An Expanded Access IND to Evaluate the Safety and Efficacy of Autologous HBadMSCs for the Treatment of a Single Pediatric Patient With Congenital Muscular Dystrophy.|
- Biological: HB-adMSCs
HB-adMSCs (Hope Biosciences autologous adipose-derived mesenchymal stem cells) is manufactured by Hope Biosciences, L.L.C., a biotechnology company headquartered in Sugar Land, Texas.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
- Subject diagnosed with LCMNA congenital muscular dystrophy.
- Subject must have banked his stem cells at Hope Biosciences LLC.
- Subject has any active infection requiring medications.
- The subject has any known coagulation anomalies.
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): NCT05154851
|United States, Texas|
|Hope Biosciences Stem Cell Research Foundation|
|Sugar Land, Texas, United States, 77478|
|Principal Investigator:||Djamchid Lotfi, MD||Investigator|
|Responsible Party:||Hope Biosciences Stem Cell Research Foundation|
|Other Study ID Numbers:||
|First Posted:||December 13, 2021 Key Record Dates|
|Last Update Posted:||August 1, 2022|
|Last Verified:||July 2022|
Muscular Disorders, Atrophic
Nervous System Diseases
Genetic Diseases, Inborn