Emcyte PureBMC for Hip Osteoarthritis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cleveland Clinic Florida, Weston, FLHip OsteoarthritisEmcyte PureBMC - CombinationProduct
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Hip Osteoarthritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Assessing change from Baseline to 6 weeks, 3 months, 6 months, and 12 months

Month 12
6 Minute Walk Test (6WMT)
Global Rate of Change
PROMIS - Pain
PROMIS - Physical Function
Month 12
6 Minute Walk Test (6MWT)
Global Rate of Change (GRoC)
Pain
PROMIS - Physical Function (PROMIS-PF)
Pittsburgh Sleep Quality Index
Western Ontario McMaster Universities Arthritis Index (WOMAC)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Triamcinolone
1 of 2
Bone marrow aspirate concentrate
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Emcyte PureBMC · No Placebo Group · Phase 3

Bone marrow aspirate concentrateExperimental Group · 2 Interventions: Aspire Needle + Emcyte PureBMC, Emcyte PureBMC · Intervention Types: CombinationProduct, CombinationProduct
Triamcinolone
Drug
ActiveComparator Group · 1 Intervention: Triamcinolone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessing change from baseline to 6 weeks, 3 months, 6 months, and 12 months

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
959 Previous Clinical Trials
1,358,856 Total Patients Enrolled
Lisa Dean Moseley FoundationUNKNOWN
LEONARDO P OLIVEIRA, MDPrincipal InvestigatorCleveland Clinic Florida
Carlos Higuera-Rueda, MDStudy DirectorCleveland Clinic Florida
1 Previous Clinical Trials
160 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 17 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) must be less than 35 kg/m2.
You have hip osteoarthritis in one or both hips.
You have received physical therapy treatment within the last 6 months for a period of 6 weeks or more.
You agree to follow the lifestyle recommendations mentioned in section 5.3.
You have been cancer-free for at least 5 years.

Who else is applying?

What state do they live in?
Ohio100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Cleveland Clinic Florida100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.