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Stem Cell Therapy
Stem Cell Treatment for Multiple Sclerosis (MS Trial)
Sugar Land, TX
Phase 2
Waitlist Available
Led By Djamchid Lotfi, MD
Research Sponsored by Hope Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an EDSS score between 3.0 to 6.5 (Patient must be able to walk)
Male and female subjects 18 - 75 years of age
Must not have
Have a systemic infection requiring treatment within 30 days prior to first dose of the investigational product
Women who are currently pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the effectiveness and safety of giving multiple injections of a specific type of stem cells through the veins to treat Multiple Sclerosis.
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Who is the study for?
This trial is for adults aged 18-75 with Relapsing Remitting Multiple Sclerosis, able to walk (EDSS score 3.0-6.5), and have banked stem cells with Hope Biosciences. They must not be pregnant or planning pregnancy, agree to use contraception, and have stable MS therapy for 6 months. Exclusions include recent infections, substance abuse, active cancer, other medical conditions that pose risks or interfere with the study.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of multiple intravenous doses of autologous HB-adMSCs in treating Multiple Sclerosis. Participants previously in a placebo group can join this study which involves patients who've stored their own mesenchymal stem cells at Hope Biosciences.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with intravenous stem cell therapies such as pain at injection site, fever, headache, nausea or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk but have some disability due to my condition.
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I am between 18 and 75 years old.
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I agree not to start or increase MS treatments during the trial.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had an infection needing treatment in the last 30 days.
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I am currently pregnant or breastfeeding.
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I do not have any active cancer.
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I haven't had any stem cell treatments in the last year, except those from Hope Biosciences.
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I do not have any neurological conditions that could affect my participation in the study.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument scores
Secondary study objectives
Change from Baseline in Expanded Disability Status Scale (EDSS) scores
Change from Baseline in Patient Health Questionnaire (PHQ-9) scores
Clinically significant changes in Multiple Sclerosis concomitant medications
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Autologous adipose-derived HB-adMSCs
Find a Location
Closest Location:Hope Biosciences Research Foundation· Sugar Land, TX· 1012 miles
Who is running the clinical trial?
Hope BiosciencesLead Sponsor
26 Previous Clinical Trials
462 Total Patients Enrolled
Djamchid Lotfi, MDPrincipal InvestigatorHope Biosciences Research Foundation
12 Previous Clinical Trials
108 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
24 Patients Enrolled for Multiple Sclerosis