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Stem Cell Therapy for Post-COVID Syndrome (HBPCOVID02 Trial)
HBPCOVID02 Trial Summary
This trial will study if a treatment involving injecting stem cells can help people with chronic symptoms after contracting Covid-19.
HBPCOVID02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHBPCOVID02 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HBPCOVID02 Trial Design
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Who is running the clinical trial?
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- I do not have fatigue caused by kidney disease or any type of anemia.I do not have any diseases that would exclude me from the trial.I have a significant health condition like diabetes, kidney disease, heart failure, or high blood pressure.I currently have an infection.I do not have any active cancer, including skin cancers.I do not plan to donate sperm/eggs or undergo IVF during the trial or within six months after.I have not taken antibiotics, antivirals, or antifungals for an infection in the last 30 days.My COPD is getting worse quickly and I often have severe symptoms.I have been diagnosed with long COVID for at least 12 weeks.I have not had thoughts of harming myself at the screening visit.I am not pregnant or breastfeeding and use reliable birth control.You have a history of being addicted to or dependent on drugs or alcohol, or you are currently using them in a harmful way.I haven't had any stem cell treatments in the last year, except those from Hope Biosciences.I am not pregnant and do not plan to become pregnant during the study and for six months after.I will use birth control during and for six months after the study if my partner can get pregnant.I am willing and able to follow the clinical trial's requirements.You have an abnormal lab test result during the screening.I am between 18 and 70 years old.I have new or worse neurological symptoms like fatigue or brain fog for over 12 weeks.My medical records show I have had Post COVID-19 Syndrome.I currently have COVID-19 with symptoms and a positive test.
- Group 1: Treatment
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What criteria must an individual meet to partake in this medical research?
"This clinical trial is seeking 80 participants aged 18-70 with confirmed Post COVID-19 Syndrome. Especially essential are those displaying symptoms such as Brain Fog, debilitating Fatigue, Headaches, Sleep Disturbances, and Loss of Taste/Smell. Furthermore, all potential patients must possess the capacity to comprehend instructions and grant written consent; additionally female enrollees are required not be pregnant or plan conception during their involvement in this study and for six months after their last investigational product administration."
Are there any other ongoing investigations into this therapeutic approach?
"Currently, 6 trials are underway, but none of those have reached the third phase. Many studies for this particular medication take place in Sugar Land, Texas; However, there exist 7 additional sites conducting research on its efficacy."
Has this particular drug regimen been granted sanction by the FDA?
"Considering prior clinical data, the safety rating of this treatment was deemed a 2. While some evidence exists in support of its security, there is yet to be any proof demonstrating efficacy."
Is this medical trial available to those over the age of thirty-five?
"Eligible participants for this trial must be over 18 years of age and not exceed the cap of 70."
Has research of this kind been previously recorded?
"This therapeutic intervention has been researched since 2020, when the first study sponsored by Hope Biosciences was conducted. This initial 24-person trial allowed for Phase 1 and 2 drug approval to be granted. Currently, 6 ongoing trials are taking place in 4 cities across one nation."
What is the primary objective of this experiment?
"This trial's primary endpoint, to be measured from the beginning of the study up until Week 26 is Serious Adverse Events (SAEs). Secondary goals encompass changes in fatigue levels, joint pain, and quality of life as measured through a Visual Analog Scale, Fatigue Assessment form. and Short Form 36 Health Survey Questionnaire respectively."
Are there openings in this experiment for participants?
"According to the data posted on clinicaltrials.gov, this medical trial is currently recruiting participants; it was first published on June 1st 2022 and has seen its most recent update occur in February 2nd of that same year."
What is the aggregate amount of individuals participating in this clinical trial?
"Affirmative, clinicaltrials.gov implies that this trial is currently enrolling participants. It was initially published on the 6th of January 2022 and revised most recently on 2nd February 2022. In total, 80 individuals are sought after by the single site running this study."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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