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Stem Cell Therapy
Autologous HB-MSCs for Multiple Sclerosis (HBMS01 Trial)
Phase 2
Waitlist Available
Led By Djamchid Lotfi, MD
Research Sponsored by Hope Biosciences Stem Cell Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights
HBMS01 Trial Summary
This trial will test whether autologous HB-adMSCs are safe and effective in treating Multiple Sclerosis, with participants receiving either the treatment or a placebo.
Who is the study for?
Adults aged 18-75 with Relapsing-Remitting Multiple Sclerosis, stabilized on MS therapy for at least 6 months. They must have banked stem cells with Hope Biosciences and not be pregnant or planning pregnancy. Contraception is required during the trial and for six months after. Excludes those with other MS types, active cancer, substance abuse, severe comorbidities, recent stem cell treatments (except from Hope Biosciences), or experimental drugs within a year.Check my eligibility
What is being tested?
The study tests the efficacy and safety of Autologous HB-adMSCs against a placebo in treating Multiple Sclerosis over one year. It involves 24 participants receiving six infusions while continuing their regular MS medications.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to infusion therapies such as discomfort at injection site, fever, chills, headache, nausea or allergic reactions; specific risks will depend on patient's condition and treatment response.
HBMS01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To investigate the efficacy of intravenous infusions of HB-adMSCs vs placebo in patients with Multiple Sclerosis as determined by improvements in the Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
Secondary outcome measures
To assess the safety of intravenous infusions of HB-adMSCs vs. Placebo in patients with Multiple Sclerosis as determined by the incidence of adverse events or serious adverse events
To determine the efficacy of intravenous infusions of HB-adMSCs vs. Placebo in patients with Multiple Sclerosis as determined by changes in 9-Hole Peg Test
To evaluate the efficacy of intravenous infusions of HB-adMSCs vs placebo in patients with Multiple Sclerosis as determined by changes in the Barthel Index
+2 moreSide effects data
From 2021 Phase 2 trial • 53 Patients • NCT0434843547%
Influenza like illness
42%
Headache
16%
Myalgia
11%
Visual impairment
11%
Nausea
11%
Muscle fatigue
5%
Back injury
5%
Ageusia
5%
Joint swelling
5%
Vertigo
5%
Leukocytosis
5%
Atrial fibrillation
5%
Corona virus Infection
5%
Back pain
5%
Dizziness
5%
Paresthesia
5%
Muscle rigidity
5%
Anosmia
5%
Fatigue
5%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allogeneic HB-adMSCs 200MM
Allogeneic HB-adMSCs 100MM
Allogeneic HB-adMSCs 50MM
Placebo
HBMS01 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Adipose derived Mesenchymal stem cells (Autologous)
Group II: PlaceboPlacebo Group1 Intervention
Normal Saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HB-adMSCs
2020
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Hope Biosciences Stem Cell Research FoundationLead Sponsor
21 Previous Clinical Trials
316 Total Patients Enrolled
Djamchid Lotfi, MDPrincipal InvestigatorHope Biosciences Stem Cell Research Foundation
11 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I do not have any active cancer, including skin cancers.I do not have a neurological condition like Charcot-Marie-Tooth or Spinocerebellar Ataxia that could affect my participation.My life expectancy is significantly affected by other serious health conditions or a history of blood disorders.I have been diagnosed with RRMS for at least 6 months.I am a man and will use birth control during and for 6 months after the study if my partner can get pregnant.I will use birth control during and for 6 months after the study if my partner can get pregnant.I do not have ongoing infections like HIV, hepatitis, or syphilis.I agree not to start or increase MS treatments during the trial.I can walk but have some disability due to my condition.I have not needed treatment for an infection with antibiotics, antivirals, or antifungals in the last 30 days.My MS type is progressive (primary, secondary, or relapsing).I am not pregnant, breastfeeding, and if of childbearing age, I use effective birth control.I have been on a stable MS treatment for at least 6 months.I haven't had any stem cell treatments in the last year, except those from Hope Biosciences.I have been diagnosed with RRMS for at least 6 months.I am not pregnant and do not plan to become pregnant during the study and for 6 months after.I am not pregnant and do not plan to become pregnant during the study and for 6 months after.I have one or more serious health issues like uncontrolled diabetes, heart problems, or recent major surgery.My latest MRI shows disease in my brain or spinal cord within the last year, with no other relapse signs.I have been on a stable MS treatment for at least 6 months.People who participate in a study should be able to read, understand, and provide written consent.I can walk but have some disability due to my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age eligibility for this experimental study limited to adults or can minors be admitted as well?
"To be included in this research, participants must have attained the age of majority and not yet surpassed their 75th birthday."
Answered by AI
What is the current enrollment count for this experiment?
"Affirmative. The information hosted on clinicaltrials.gov declares that this medical trial, first posted on November 24th 2021, is actively searching for potential participants. A maximum of 24 patients need to be recruited from one different medical site."
Answered by AI
What are the criteria for enrolment in this experiment?
"This medical trial is seeking 24 patients with multiple sclerosis, aged between 18 and 75. These are the minimum criteria for enrollment."
Answered by AI
Is this research protocol recruiting participants at present?
"Going by the information available on clinicaltrials.gov, this investigation is currently accepting participants. This trial was initially advertised on November 24th 2021 and has since been updated to its current status as of May 21st 2022."
Answered by AI
Has the FDA granted approval to utilize HB-adMSCs?
"Data supporting HB-adMSCs' safety has been gathered, thus it received a score of 2. However, no clinical data exists to indicate its efficacy as this is only Phase 2."
Answered by AI
Is this trial a groundbreaking endeavor for medical science?
"Presently, 6 studies for HB-adMSCs are in progress across 4 cities and 1 nation. The initial experiment on this subject was commissioned by Hope Biosciences back in 2020; it included 24 patients & completed its Phase 1&2 drug approval process. Since then, a staggering 18,329 trials have been conducted."
Answered by AI
Could you provide a comprehensive overview of the experiments involving HB-adMSCs which have been conducted to date?
"Currently, 6 investigations are underway examining the efficacy of HB-adMSCs. None of these trials have reached phase 3 yet; however, there is a range of medical centres across 7 locations that are conducting research related to this medication. The majority of experiments centered around HB-adMSCs are taking place in Sugar Land, Texas."
Answered by AI
Who else is applying?
What state do they live in?
Texas
South Carolina
How old are they?
18 - 65
What site did they apply to?
Hope Biosciences Stem Cell Research Foundation
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Hope Biosciences Stem Cell Research Foundation: < 48 hours
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