Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Karmy Clinic, Brampton, Canada
Arthrosis
Bone Marrow Aspirate, Lipoaspirate Concentrate - Biological
Eligibility
18+
All Sexes
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Study Summary

The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 90, 180, 360 days

360 days
The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale
90, 180 days
Change from Baseline to Days 90, 180 in WOMAC pain subscale
90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in Patient's Global Impression of Changes (PGIC)
Change from Baseline to Days 90, 180, and 360 in WOMAC function subscale
Change from Baseline to Days 90, 180, and 360 in WOMAC stiffness subscale
Change from Baseline to Days 90, 180, and 360 in total WOMAC score
Change in average weekly consumption of analgesic medications from Baseline to Day 90, 180, and 360

Trial Safety

Trial Design

2 Treatment Groups

Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
1 of 2
Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
1 of 2
Active Control

400 Total Participants · 2 Treatment Groups

Primary Treatment: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate · No Placebo Group · Phase 2

Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
Biological
ActiveComparator Group · 1 Intervention: Bone Marrow Aspirate, Lipoaspirate Concentrate · Intervention Types: Biological
Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
Biological
ActiveComparator Group · 1 Intervention: Bone Marrow Aspirate, Lipoaspirate Concentrate · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90, 180, 360 days
Closest Location: Karmy Clinic · Brampton, Canada
N/AFirst Recorded Clinical Trial
0 TrialsResearching Arthrosis
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to comply with the study procedures and phone visit schedules and are able to follow verbal and written instructions.
You have given written informed consent to participate in the study.\n
A score of 4-9 (moderate to severe pain) on the NRS pain scale.
You have had knee or hip osteoarthritis for at least 12 weeks prior to screening.
You have radiographic evidence of OA of the knee or hip.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.