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Stem Cell Therapy for Brain Injury
Study Summary
This trial will test whether it is safe to give patients brain injury an infusion of HB-adMSC cells, and whether these cells improve brain function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 53 Patients • NCT04348435Trial Design
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Who is running the clinical trial?
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- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
How many participants are currently partaking in this clinical experiment?
"This clinical trial is no longer accepting applicants. The study was first published on January 1, 2020 and its details were last updated on May 27, 2022. If you're still searching for studies to participate in, there are 1047 trials recruiting patients with brain diseases and 6 additional ones seeking participants diagnosed with HB-adMSCs."
Are there any contemporaneous research projects involving HB-adMSCs?
"Presently, there are 6 medical trials involving HB-adMSCs. None of these experiments have reached the third phase yet. While most research is being conducted in Sugar Land, Texas, there are also 7 other clinical sites running studies on this treatment option."
Does this research study allow individuals over 35 years of age to participate?
"This trial is open to those aged 18-55, while there are other trials available for both younger and older patients. Specifically, 216 studies cater to minors and 802 focus on geriatric demographics."
For whom would this clinical trial be a suitable option?
"This clinical trial is taking applications from 18-55 year olds who are suffering from a neurological condition that has been present for over 6 months. Furthermore, applicants must have a Glasgow Outcome Scale score between 2 and 6 inclusive, the ability to obtain consent or be represented by an LAR, and fluency in either English or Spanish (for validated neurocognitive testing). A total of 24 participants will receive treatment."
Is the recruitment for this clinical trial still ongoing?
"At this time, no new participants are being welcomed into this research. The trial was first posted in January 2020 and the latest update on it occurred May 27th 2022. However, if you're looking for other trials to join, there are 1047 studies actively seeking volunteers with brain diseases and 6 studies that involve HB-adMSCs accepting applicants."
What is the ultimate goal of this clinical investigation?
"The main metric being measured in this trial is Absolute Lymphs, which will be recorded at Screening (visit 1),change from screening at visit 3, change from screening at visit 4, change from screening at visit 5, change from screening at 6 months post-infusion (visit 6) and lastly Change from Screening at one year post-infusion (Visit 7). Secondary outcomes include Whole brain MRI using DTI to evaluate both macro and microstructural features; Verbal Fluency Test for vocabulary size assessment as well as rapidity of lexical access, updating prowess and inhibition quality; Glasgow Outcome Score"
Does this trial represent a pioneering approach in its field?
"Currently, 6 clinical trials utilising HB-adMSCs are active over 4 cities and 1 nation. Initially conducted in 2020 by Hope Biosciences with 24 participants, Phase 1 & 2 drug approval stage was successfully reached. Since its inception 5 years ago, the study has seen a total of five completed trials."
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How responsive is this trial?
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Most responsive sites:
- Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU): < 24 hours
Average response time
- < 1 Day
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