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Mesenchymal Stem Cell Therapy

Autologous bone marrow aspirate will be harvested and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to site of operation for Cartilage Injury

N/A

Waitlist Available

Led By Adam Yanke, MD

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

• Patients aged 18-50 with a cartilage defect indicated for treatment with osteochondral allograft

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks

Awards & highlights

Study Summary

This trial is testing whether a stem cell injection improves joint function after an osteochondral allograft (a joint replacement).

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, post-operative 2 weeks, 6 weeks, 12, weeks, 24 weeks, 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Synovial Fluid Cytokine Measurement

Other outcome measures

Computed Tomography (CT) analysis

Radiographic analysis

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bone Marrow Aspiration GroupExperimental Treatment1 Intervention

A bone marrow aspiration will be performed from the iliac crest. The bone marrow aspirate will be processed using a bone marrow aspirate concentrate (BMAC) harvesting system. The osteochondral allograft plug will then be soaked in the BMAC for a minimum 2 minutes prior to implantation. The remaining BMAC will be placed in the defect site prior to plug implantation.

Group II: ControlPlacebo Group1 Intervention

The control group will receive a 0.5cm sham incision over the iliac crest, but bone marrow aspiration will not be performed. The osteochondral allograft plug will not be soaked in BMAC prior to implantation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Autologous bone marrow aspirate will be harvested and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to site of operation

2018

N/A

~40

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,498 Total Patients Enrolled

Joint Restoration FoundationOTHER

Joint Restoration Foundation (JRF)UNKNOWN

Frequently Asked Questions

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

How many trial participants are currently enrolled in this experiment?

"Affirmative. Clinicaltrials.gov has the latest information on this trial, which was initially posted on March 2nd 2018 and recently modified in February 2022. 40 participants are being recruited from a single medical centre for participation."

Answered by AI

Does the protocol for this investigation extend to individuals over twenty years old?

"The preliminary enrolment criteria for this clinical trial is a patient age range between 18 and 50 years old."

Answered by AI

To what demographic of participants does this clinical trial apply?

"Eligible candidates for this clinical trial will be between 18 and 50 years old with a history of cartilage injury. The medical study is looking to recruit approximately 40 participants."

Answered by AI

Are any additional participants able to join this trial?

"This research study is seeking participants as per the data hosted on clinicaltrials.gov, which was initially posted in March 2018 and amended most recently in February 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation

2018. "Autologous Bone Marrow Concentrate in Knee Osteochondral Allograft Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04739930.