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Autologous cell therapy

PRP + Cell Therapy for Osteoarthritis

Phase 2
Recruiting
Research Sponsored by Dr. Grant M. Pagdin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female at least 19 years of age at the time of providing written informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the sf12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). to test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).
Awards & highlights

Study Summary

This trial is testing whether combining platelet-rich plasma (PRP) with either lipoaspirate or bone marrow aspirate can improve outcomes in osteoarthritis patients, compared to using PRP alone.

Who is the study for?
This trial is for adults over 19 with Osteoarthritis in a major joint, confirmed by recent imaging. They must be able to consent and follow the study plan. Excluded are those with BMI >35, recent joint surgery or injections, certain medication restrictions, severe arthritis (Grade 4), low platelet or hemoglobin levels, active infection or cancer, pregnant women, and those with autoimmune diseases or allergies to specific medications.Check my eligibility
What is being tested?
The trial tests how effective PRP therapy combined with lipoaspirate and/or bone marrow aspirate is for Osteoarthritis. Participants will receive one of three treatment combinations: PRP plus lipoaspirate; PRP plus bone marrow aspirate; or PRP with both lipoaspirate and bone marrow aspirate.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection sites, swelling, bruising from needle insertion for collecting fat/bone marrow cells used in treatments. There's also a risk of infection post-procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 19 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the vas will be measured at baseline (week 1) through to the end of the study (week 104). to test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).
This trial's timeline: 3 weeks for screening, Varies for treatment, and the vas will be measured at baseline (week 1) through to the end of the study (week 104). to test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline through to end of study for the Visual Analogue Scale (VAS).
Changes from baseline through to the end of study for the Short Form 12 item version 2 (SF12-v2)
Secondary outcome measures
Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) baseline visit through to end of study.
Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) from baseline visit through to end of study.
Flow cytometry

Trial Design

3Treatment groups
Active Control
Group I: Group A - PRP plus LipoaspirateActive Control1 Intervention
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.
Group II: Group B - PRP plus Bone Marrow AspirateActive Control1 Intervention
Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.
Group III: Group C - PRP plus Lipoaspirate plus Bone Marrow AspirateActive Control1 Intervention
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate) plus bone marrow aspirate. Total Volume varies by joint.

Find a Location

Who is running the clinical trial?

Dr. Grant M. PagdinLead Sponsor
Stephen Rosenfeld, MDStudy ChairQuorum Review IRB

Media Library

Autologous cell therapy (Autologous cell therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03984461 — Phase 2
Osteoarthritis Research Study Groups: Group A - PRP plus Lipoaspirate, Group B - PRP plus Bone Marrow Aspirate, Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate
Osteoarthritis Clinical Trial 2023: Autologous cell therapy Highlights & Side Effects. Trial Name: NCT03984461 — Phase 2
Autologous cell therapy (Autologous cell therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03984461 — Phase 2
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03984461 — Phase 2

Frequently Asked Questions

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

Is the subject pool for this study open to participants of an advanced age?

"This medical study is searching for participants aged between 19 and 79 years of age."

Answered by AI

Are there any current opportunities to get involved in this experiment?

"As per the information on clinicaltrials.gov, this investigation is still open to enrolment and has been accepting candidates since September 1st 2020. The data was last revised on the 26th of September 2022."

Answered by AI

How many participants have enrolled in this research initiative?

"Affirmative. Per the information available on clinicaltrials.gov, this research is currently enrolling participants who were initially solicited on September 1st 2020. The trial requires 240 individuals to be recruited from one medical centre and was last updated at the end of September 2022."

Answered by AI

How hazardous is the Group B - PRP and Bone Marrow Aspirate procedure for participants?

"Because this Phase 2 trial only has evidence backing its safety, our squad at Power gave Group B - PRP plus Bone Marrow Aspirate a rating of two."

Answered by AI

What demographic is eligible to participate in this trial?

"Participants must have arthrosis and fall between the ages of 19-79 to be considered for acceptance into this clinical trial. Approximately 240 individuals will be selected to participate."

Answered by AI

Who else is applying?

What state do they live in?
British Columbia
What site did they apply to?
Pagdin Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How often would I have to travel to Kelowna? How long would I have to stay in Kelowna? Could I have the injections completed in North Vancouver/Vancouver?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I have arthritis in both hands, with the right hand being more advanced. There is joint deformity in the base of the 1st metacarpals, with loss of strength in both hands. The head of the 2nds MCP is inflamed. There have not been any medications or injections yet. Pain is controlled by Tylenol and Ibuprofin.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Pagdin Health: < 24 hours
Typically responds via
Email
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
The Combined Use of PRP With Lipoaspirate and/or Bone Marrow Aspirate in Osteoarthritis
Dr. Grant M. Pagdin 2020. "The Combined Use of PRP With Lipoaspirate and/or Bone Marrow Aspirate in Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03984461.
All > Osteoarthritis > Oa
~72 spots leftby Dec 2025
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