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Stem Cell Therapy

Investigational Arm for Anterior Cruciate Ligament Injury

Phase 4

Waitlist Available

Led By Miguel Otero, Ph.D.

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

Awards & highlights

Study Summary

This trial aims to study the effectiveness of concentrated bone marrow aspirate (cBMA) in reducing symptoms of post traumatic osteoarthritis (PTOA) in patients having revision anterior cruciate lig

Who is the study for?

This trial is for individuals who have had a previous ACL (Anterior Cruciate Ligament) reconstruction and are now in need of a revision surgery. They should be experiencing symptoms related to post-traumatic osteoarthritis. Specific eligibility criteria details were not provided.Check my eligibility

What is being tested?

The study is testing the effectiveness of concentrated bone marrow aspirate (cBMA) injections during revision ACL surgery, compared to standard care with sham incision. It aims to see if cBMA can reduce pain and inflammation markers after surgery.See study design

What are the potential side effects?

Potential side effects were not detailed, but may include typical risks associated with surgical procedures such as infection, bleeding, or reactions at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 6 months, 12 months and 24 months post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in patient reported knee pain

Secondary outcome measures

Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization

Change from baseline in cartilage morphology

Concentration of circulating inflammatory biomarkers

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational ArmExperimental Treatment2 Interventions

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).

Group II: Control ArmPlacebo Group2 Interventions

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,324 Total Patients Enrolled

3 Trials studying Anterior Cruciate Ligament Injury

136 Patients Enrolled for Anterior Cruciate Ligament Injury

Arthritis FoundationOTHER

34 Previous Clinical Trials

46,111 Total Patients Enrolled

Emory UniversityOTHER

1,636 Previous Clinical Trials

2,560,533 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research study open to individuals older than 60 years?

"Individuals aged between 18 and 55 are eligible to apply for this study based on the inclusion criteria. Notably, there are a substantial number of clinical trials available for individuals under 18 years old (207 trials) as well as those over the age of 65 (1277 trials)."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"As per the information on clinicaltrials.gov, this research investigation is presently not enrolling volunteers. The trial was originally listed on 4/1/2024 and last revised on 3/8/2024. While this specific study is inactive in terms of patient recruitment, it's noteworthy that there are currently 1514 other trials actively seeking participants."

Answered by AI

What is the safety profile of the experimental treatment arm for individuals participating in the study?

"In this Phase 4 trial, the Investigational Arm's safety rating is a solid 3 according to our evaluation at Power. This score reflects that the treatment has already received regulatory approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

2024. "Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06311513.

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