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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, 9 months, 12 months, 24 months
Awards & highlights
BMAC Trial 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.Check my eligibility
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.See study design
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.
BMAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English.
BMAC Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Signal to Noise Quotient
Secondary outcome measures
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 moreBMAC 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.
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,431 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a ligament injury alongside my main condition.I haven't had PRP or similar treatments for my knee in the last year.I am not pregnant or breastfeeding and agree to use birth control during the study.You have a medical condition that could be dangerous, impact the study, or make it difficult for you to complete the study.I am at high risk for bleeding or infection after surgery due to my condition or medications.I have HIV or active Hepatitis B/C.I am scheduled for or have had a revision surgery.I am between 18 and 60 years old and need ACL surgery within 6 months of injury using a patellar tendon from a donor.I speak English.I am unable to make my own medical decisions.I have had knee surgery in the past.You cannot get an MRI scan.I have musculoskeletal cancer or another type of cancer not in long-term remission.You have a history of alcohol or drug abuse.
Research Study Groups:
This trial has the following groups:- Group 1: Mesenchymal Stem Cell Recipient
- Group 2: Control Sham Incision
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still recruiting participants for this research initiative?
"As detailed on clinicaltrials.gov, this medical study is no longer recruiting participants; the trial was first posted in November 2017 and its most recent update occurred in March 2022. However, there are currently 174 other studies that accept patients to take part in them."
Answered by AI
Are elderly individuals being included in the enrollment process of this experiment?
"This clinical trial seeks applicants aged 18 to 60. For those younger than the specified age, 58 different studies are available; for seniors above 65 years old, 71 different options exist."
Answered by AI
What eligibility criteria must be met to join this trial?
"To be eligible to participate, volunteers must possess a rupture and fall into the age range of 18-60 years old. This particular trial is recruiting 100 individuals in total."
Answered by AI
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