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Stem Cell Therapy

BMAC vs Triamcinolone for Hip Osteoarthritis

Q: Are patient volunteers currently being enrolled in this experiment?

<p>No, this particular study is no longer looking for participants. It was first posted on January 10th, 2023 but the most recent update was on October 16th, 2022. Although this trial has completed recruitment, there are 725 other clinical trials that are still looking for patients.</p>

Phase 3

Waitlist Available

Led By LEONARDO P OLIVEIRA, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

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

Must have

Unilateral or Bilateral Hip Osteoarthritis

Prior physical therapy treatment for 6 weeks in the last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

Awards & highlights

Study Summary

This trial is testing whether bone marrow aspirate concentrate (BMAC) is more effective than Triamcinolone in reducing pain and improving function in patients with hip osteoarthritis.

Who is the study for?

This trial is for men and women aged 18-65 with hip osteoarthritis, who have had physical therapy but no recent corticosteroid injections or active autoimmune diseases. Participants must not be pregnant, planning pregnancy, or have a history of certain medical conditions like uncontrolled diabetes or thyroid dysfunction.Check my eligibility

What is being tested?

The study compares the effectiveness of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in reducing pain and improving function in hip osteoarthritis patients. It measures outcomes through patient-reported scores and performance on a walking test over 12 months.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, infection risk from needle insertion, allergic reactions to components used during the procedure, and general risks associated with bone marrow aspiration.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have arthritis in one or both of my hips.

Select...

I have undergone physical therapy for 6 weeks in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Western Ontario McMaster Universities Arthritis Index (WOMAC)

Secondary outcome measures

6 Minute Walk Test (6MWT)

Other outcome measures

Global Rate of Change (GRoC)

Pain

PROMIS - Physical Function (PROMIS-PF)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bone marrow aspirate concentrateExperimental Treatment1 Intervention

Bone marrow that is aspirated then concentrated using a device.

Group II: TriamcinoloneActive Control1 Intervention

Triamcinolone is a corticosteroid.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,365,976 Total Patients Enrolled

Lisa Dean Moseley FoundationUNKNOWN

LEONARDO P OLIVEIRA, MDPrincipal InvestigatorCleveland Clinic Florida

Media Library

Emcyte PureBMC (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04990128 — Phase 3

Hip Osteoarthritis Research Study Groups: Bone marrow aspirate concentrate, Triamcinolone

Hip Osteoarthritis Clinical Trial 2023: Emcyte PureBMC Highlights & Side Effects. Trial Name: NCT04990128 — Phase 3

Emcyte PureBMC (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04990128 — Phase 3

Frequently Asked Questions

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

What is Emcyte PureBMC's primary purpose?

"Emcyte PureBMC is a versatile treatment that can be used to manage ulcerative colitis, as well as other disorders such as hand, brain, and dermatologic disorders."

Answered by AI

Could you explain the age range for people who can participate in this experiment?

"This particular trial is seeking patients that fall between 18 and 65 years of age. Out of the 728 similar trials, 41 are for patients younger than 18 and 687 are for patients older than 65."

Answered by AI

Out of how many people who applied, how many have been selected to participate in this experiment?

"Unfortunately, this particular trial is no longer seeking patients for participation. The trial was originally posted on 1/10/2023 and last edited on 10/16/2022. However, there are 678 other trials for hip joint patients and 47 trials for Emcyte PureBMC patients that are still looking for participants."

Answered by AI

What are the risks associated with using Emcyte PureBMC?

"Emcyte PureBMC has been evaluated for safety and given a 3. This is based on it being a Phase 3 trial, which means that there is both efficacy data and multiple rounds of safety data available."

Answered by AI

What is the general efficacy of Emcyte PureBMC in a clinical setting?

"At the moment, there are 47 clinical trials underway that are looking into Emcyte PureBMC. 8 of those studies are in the third and final phase. The majority of trials for Emcyte PureBMC are taking place in Columbia, Missouri, but there are a total of 80 locations running trials for this potential treatment."

Answered by AI

Who does this trial's screening process accept?

"This trial is looking for 100 participants who currently have hip joint pain and meet the following criteria:-Willingness to comply with all study procedures and availability for the duration of the study-Agreement to adhere to Lifestyle Considerations-Provision of signed and dated consent form-Male or female, aged between 18 - 65 years old-WOMAC ≥ 50-Kellgren-Lawrence Grade 2 or higher on Hip X-Rays-Body Mass Index < 35 kg/m2-Unilateral or Bilateral Hip Osteoarthritis-Prior physical"

Answered by AI

Are patient volunteers currently being enrolled in this experiment?

"No, this particular study is no longer looking for participants. It was first posted on January 10th, 2023 but the most recent update was on October 16th, 2022. Although this trial has completed recruitment, there are 725 other clinical trials that are still looking for patients."

Answered by AI