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Cell Therapy

CAP-1002 for Duchenne Muscular Dystrophy (HOPE-2-OLE Trial)

Phase 2
Waitlist Available
Led By Craig McDonald, MD
Research Sponsored by Capricor Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 12, month 24, month 36, and month 48 timepoint
Awards & highlights

HOPE-2-OLE Trial Summary

This trial will provide CAP-1002 to subjects who completed the HOPE-2 trial and will explore the safety and efficacy of eight intravenous administrations of CAP-1002, each separated by three months.

Who is the study for?
This trial is for those who were in the HOPE-2 study, finished a year of follow-up, and can give consent. They must have good veins for infusions and be able to stick to the trial plan. People with planned major surgery, recent investigational drug use, substance abuse issues, or severe respiratory problems can't join.Check my eligibility
What is being tested?
The safety and effectiveness of CAP-1002 are being tested through sixteen intravenous doses given every three months over two years. Participants will have regular check-ups before each dose to monitor their response to the treatment.See study design
What are the potential side effects?
Potential side effects aren't detailed here but could relate to infusion reactions due to CAP-1002's components like DMSO or bovine products; participants with known hypersensitivity to these are excluded.

HOPE-2-OLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 12, month 24, month 36, and month 48 timepoint
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 12, month 24, month 36, and month 48 timepoint for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary efficacy endpoint is change in upper limb function
The primary safety endpoint is the incidence and severity of all treatment-emergent adverse events
Secondary outcome measures
Change from baseline in upper limb function
Change from from baseline in distal-level (wrist and hand) upper limb function
Change from from baseline in mid-level (elbow) upper limb function
+2 more

HOPE-2-OLE Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label armExperimental Treatment1 Intervention
Open-label CAP-1002 will be administered to all subjects enrolled in the trial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAP-1002
2018
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Capricor Inc.Lead Sponsor
11 Previous Clinical Trials
475 Total Patients Enrolled
Mark AwadallaStudy DirectorCapricor Inc.
3 Previous Clinical Trials
162 Total Patients Enrolled
Craig McDonald, MDPrincipal InvestigatorUC Davis
4 Previous Clinical Trials
736 Total Patients Enrolled

Media Library

CAP-1002 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04428476 — Phase 2
Duchenne Muscular Dystrophy Research Study Groups: Open-label arm
Duchenne Muscular Dystrophy Clinical Trial 2023: CAP-1002 Highlights & Side Effects. Trial Name: NCT04428476 — Phase 2
CAP-1002 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04428476 — Phase 2
~3 spots leftby Jun 2025
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