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Stem Cell Therapy

Stem Cell Injections for Osteoarthritis

Phase 2
Recruiting
Led By Grigory Karmy, MD
Research Sponsored by Grigory Karmy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18 to 95 years old
Residents of Canada
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90, 180, 360 days
Awards & highlights

Study Summary

This trial is comparing the effects of two different injections on reducing pain and improving function for people with knee or hip OA.

Who is the study for?
This trial is for Canadian residents aged 18-95 with moderate to severe knee or hip osteoarthritis pain, who've tried treatments like physiotherapy, injections, and oral painkillers. They must be able to follow the study plan and have a BMI ≤ 50 kg/m2. People with autoimmune diseases, allergies to certain anesthetics or anticoagulants, or metal implants in the affected joint cannot join.Check my eligibility
What is being tested?
The study tests if one injection of Lipoaspirate Concentrate (fat-derived cells) is more effective than Bone Marrow Aspirate (bone marrow-derived cells) at reducing pain and improving function in osteoarthritic knees and hips.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, swelling, infection risk increase due to the procedure itself rather than from the substances injected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 95 years old.
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My average pain level is between moderate and severe.
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Your body weight is within a healthy range, and not excessively high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90, 180, 360 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90, 180, 360 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale
Secondary outcome measures
Change from Baseline to Days 90, 180 in WOMAC pain subscale
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
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow AspirateActive Control1 Intervention
The subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Groups C will receive a single intra-articular injection with lipoaspirate concentrate to the hip and Group D will receive a single intra-articular injection with bone marrow aspirate.
Group II: Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow AspirateActive Control1 Intervention
The Subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Group A will receive a single intra-articular injection with lipoaspirate concentrate to the knee and Group B will receive a single intra-articular injection with bone marrow aspirate concentrate.

Find a Location

Who is running the clinical trial?

Grigory KarmyLead Sponsor
Grigory Karmy, MDPrincipal InvestigatorMcMaster University

Media Library

Bone Marrow Aspirate (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05507099 — Phase 2
Osteoarthritis Research Study Groups: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate, Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
Osteoarthritis Clinical Trial 2023: Bone Marrow Aspirate Highlights & Side Effects. Trial Name: NCT05507099 — Phase 2
Bone Marrow Aspirate (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507099 — Phase 2
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05507099 — Phase 2

Frequently Asked Questions

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

Are individuals aged 30 and over eligible for this experimental protocol?

"This trial is open to participants of legal age (18+) and those who have not yet reached 95 years of life."

Answered by AI

Is there an ongoing initiative to involve participants in this research?

"Affirmative, the clinical trial is recruiting according to the data on clinicaltrials.gov. This investigation was initially announced on August 8th 2022 and has since been amended multiple times with its most recent update being dated 17th of August in the same year; obtaining 400 participants across a single site."

Answered by AI

How many participants are included in the current trial?

"Affirmative. Clinicaltrials.gov indicates that this trial is actively pursuing participants, having first been posted on August 8th 2022 and most recently updated on the 17th of the same month. 400 patients are being sought out from a single site for enrollment purposes."

Answered by AI

What health risks are associated with the administration of Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate?

"A score of 2 was assigned to the safety of Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate due to limited evidence from Phase 2 trials demonstrating its safety, but no efficacy data available."

Answered by AI

Who meets the criteria to join this clinical study?

"This medical trial has opened up recruitment for 400 patients suffering from arthrosis, aged between 18 and 95 years old. Notably, potential participants must be willing to adhere to the study's protocol as well as its phone visitation schedule; they should also possess the capacity to comprehend both spoken and written instructions. Moreover, interested parties need to provide their consent in writing before being eligible for enrolment. Furthermore, a numerical rating scale (NRS) of 4-9 is necessary in order to calculate an average score that reflects moderate or severe pain associated with knee or hip osteoarthritis which has been present for at least twelve weeks prior screening period -"

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Washington
Texas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+
What site did they apply to?
Karmy Clinic

What questions have other patients asked about this trial?

Is there a hospital stay? Since I live in Waterloo, quite far, is there any travel compensation (gas) ?
PatientReceived no prior treatments

Why did patients apply to this trial?

Trying to avoid TKR. Pain in my knees and hips. I do not want knee replacement surgery.
PatientReceived 1 prior treatment
Looking to better manage my osteoarthritis so I can stay active while minimizing knee pain and swelling.
PatientReceived no prior treatments
My left knee very weak , my GP told me that I have osteoporosis symptoms also my fingers joints like swollen.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Karmy Clinic: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
Grigory Karmy 2022. "Stem Cell Study in Osteoarthritis of the Knee and Hip Joints". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05507099.
All > Osteoarthritis
~267 spots leftby Aug 2028
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