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

Must not have

History of non DMD-related chronic respiratory disease including, but not limited to, asthma, bronchitis, and tuberculosis

Planned or likely major surgery in the next 12 months after planned first infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at month 12, month 24, month 36, month 48, and month 60 timepoint

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic lung condition not related to muscular dystrophy.

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I am likely to have major surgery within a year after starting treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 12, month 24, month 36, month 48, and month 60 timepoint

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 12, month 24, month 36, month 48, and month 60 timepoint

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 12, month 24, month 36, month 48, and month 60 timepoint for reporting.