The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

Dr. Grant M. Pagdin

Status and phase: Enrolling; Phase 2

Conditions: Osteoarthritis

Treatments: Biological: Autologous cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03984461

OASC2015

Details and patient eligibility

About

To demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

Full description

The purpose of this study is to demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

A total of 240 participants will be randomly assigned to one of three treatment groups: Group A will receive PRP plus lipoaspirate, Group B will receive PRP plus bone marrow aspirate, and Group C will receive tri-partite therapy of PRP + lipoaspirate + bone marrow aspirate which allows for 80 in each group. The combination of biologic materials will be injected in to an arthritic joint.

Enrollment: 240 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
2. Male or female at least 19 years of age at the time of providing written informed consent.
3. Evidence of OsteoArthritis in a major joint requires recent (within one year) imaging, either by x-ray or MRI. Kellgren & Lawrence Grades 1-3 are accepted for participation.

Exclusion criteria

1. BMI > 35
2. Arthroscopic surgery to the treatment joint within 12 months
3. Cortisone or HA injection within the last 3 months prior to stem cell injection
4. Inability to hold antiplatelet therapy according to treating provider prior to procedure
5. Kellgren & Lawrence Grade 4 Osteoarthritis
6. Participants with a platelet count less than 100 x 109
7. Participants with a Hemoglobin less than 100 g/L
8. Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
9. Participants with an active Cancer diagnosis.
10. Participants with autoimmune disorders including rheumatoid arthritis and lupus.
11. Women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. Female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study.
12. Participants with allergies to lidocaine, heparin, or epinephrine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Group A - PRP plus Lipoaspirate

Active Comparator group

Description:

Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.

Treatment:

Biological: Autologous cell therapy

Group B - PRP plus Bone Marrow Aspirate

Active Comparator group

Description:

Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.

Treatment:

Biological: Autologous cell therapy

Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate

Active Comparator group

Description:

Equal proportions of PRP plus micronized adipose tissue (lipoaspirate) plus bone marrow aspirate. Total Volume varies by joint.

Treatment:

Biological: Autologous cell therapy