Autologous Adipose Derived Mesenchymal Stromal Cells for Osteoarthritis

Mayo Clinic in Rochester, Rochester, MN
OsteoarthritisAutologous Adipose Derived Mesenchymal Stromal Cells - Drug
Eligibility
18 - 65
All Sexes

Study Summary

This trial is testing whether a certain type of injection is safe and effective for treating hip pain caused by arthritis.

Treatment Effectiveness

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: For a period of 2 years following last injection

Month 1
Change in synovial fluid biomarkers within the target hip
Month 12
Change in cartilage morphology
Change in cartilage thickness
Change in cartilage volume
Change in radiographic joint morphology
Change in subchondral bone morphology
Change periarticular soft-tissues
Month 12
Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles
Change in Tegner activity scale in the target hip following completion of treatment cycles
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles
Change in modified Harris Hip Score (mHHS) in the target hip following completion of treatment cycles
Year 2
Nature, incidence and severity of adverse events (AEs)

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Single Injection
1 of 2
Two Injections
1 of 2

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Autologous Adipose Derived Mesenchymal Stromal Cells · No Placebo Group · Phase 1

Single Injection
Drug
Experimental Group · 1 Intervention: Autologous Adipose Derived Mesenchymal Stromal Cells · Intervention Types: Drug
Two Injections
Drug
Experimental Group · 1 Intervention: Autologous Adipose Derived Mesenchymal Stromal Cells · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: for a period of 2 years following last injection

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,008 Previous Clinical Trials
3,513,445 Total Patients Enrolled
28 Trials studying Osteoarthritis
2,820 Patients Enrolled for Osteoarthritis
Aaron J KrychPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
275 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your hip that needs treatment is stable and not getting worse.

Who else is applying?

What state do they live in?
Arizona100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Mayo Clinic in Rochester100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

How many participants are currently enrolling in this clinical exploration?

"Affirmative. Information published on clinicaltrials.gov attests that this medical research is now looking for participants - it was first launched on the 5th of November 2018 and last updated on December 2nd 2022. 24 volunteers need to be recruited from one trial centre." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts underway to include participants in this research?

"Affirmative. According to clinicaltrials.gov, this trial is actively enrolling participants at present and was initially posted on the 5th of November 2018 before being updated most recently on 2nd December 2022. A total of 24 patients need to be recruited from one site in particular." - Anonymous Online Contributor

Unverified Answer

Are individuals who are 25 years or older eligible for participation in this trial?

"This study is onboarding participants of legal age and under 65 years old." - Anonymous Online Contributor

Unverified Answer

What criteria must be satisfied in order to enroll in this research program?

"This clinical trial, which is recruiting approximately 24 patients, requires all participants to have osteoarthritis of the hip and be aged 18-65." - Anonymous Online Contributor

Unverified Answer

Is Autologous Adipose Derived Mesenchymal Stromal Cells a secure option for individuals?

"Autologous Adipose Derived Mesenchymal Stromal Cells have been assigned a safety rating of 1 due to the fact that this is still an early phase trial, with restricted evidence pointing toward its efficacy and security." - 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.