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Mesenchymal Stem Cells

Mesenchymal Stem Cell Augmentation for ACL Injury (BMAC Trial)

N/A

Waitlist Available

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

English-speaking patients

Be between 18 and 65 years old

Must not have

Concomitant ligamentous injury

Pregnant or breast feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 9 months, 12 months, 24 months

Summary

This trial will test whether adding bone marrow cells to ACL surgery helps the knee heal and recover better.

Who is the study for?

This trial is for English-speaking adults aged 18-60 with a recent ACL injury who are getting patellar tendon allograft reconstruction. Candidates must be able to follow up and have an MRI. Excluded are those with HIV, hepatitis, prior knee surgery, psychiatric illnesses affecting study comprehension or follow-up, other ligament injuries, cancer (unless in long-term remission), substance abuse issues, pregnancy or breastfeeding women, and anyone at risk of bleeding or infection.

What is being tested?

The study tests if injecting one's own bone marrow-derived mesenchymal stem cells into the reconstructed ACL improves healing compared to a sham procedure. Healing is monitored via MRI scans and patient-reported outcomes alongside objective functional assessments.

What are the potential side effects?

Potential side effects may include pain at the injection site, infection risks associated with any surgical procedure, allergic reactions to materials used during the process and complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English.

Exclusion Criteria

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

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I have a ligament injury alongside my main condition.

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I am not pregnant or breastfeeding and agree to use birth control during the study.

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I have HIV or active Hepatitis B/C.

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I am scheduled for or have had a revision surgery.

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I am unable to make my own medical decisions.

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I have had knee surgery in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 9 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 9 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 9 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Signal to Noise Quotient

Secondary study objectives

Patient reported outcomes- International Knee Documentation Committee (IKDC) Score

Patient reported outcomes- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)

Patient reported outcomes- Tegner Score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mesenchymal Stem Cell RecipientExperimental Treatment1 Intervention

Patients in this group will receive between 1-4 ml of bone marrow aspirate concentrate (BMAC) containing mesenchymal stem cells (MSCs) obtained from their iliac crest. A small incision will be made on the anterior superior iliac spine in order to withdraw the aspirate. The aspirate will be ran through a centrifuge in order to isolate the BMAC containing MSCs. The BMAC will be injected into the ACL allograft prior to implanting into the patient.

Group II: Control Sham IncisionPlacebo Group1 Intervention

Patients will receive a sham incision on the anterior superior iliac spine where the bone marrow aspirate is obtained in the the experimental group. This ensures proper blinding. The patient will receive the normal standard of care.

0 / 7Eligibility criteria met