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Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis (BMAC)

Primary Purpose

Bilateral Primary Osteoarthritis of Knee

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Autologous Bone Marrow Aspirate Concentrate

Sterile saline

About this trial

This is an interventional treatment trial for Bilateral Primary Osteoarthritis of Knee focused on measuring osteoarthritis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and Female subjects are both eligible
Subjects must be 18 years of age or older
Subjects must have bilateral OA and pain in both knees.
Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-3.
Subjects must have previously tried 6 weeks of one of the following conservative treatments Activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy
Patients can provide written informed consent after the nature of the study is fully explained

Exclusion Criteria:

Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
Patients receiving injections to the treated knee within 2 months prior to study entry.
Patients who are pregnant or currently breast-feeding children.
Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
Patients with ongoing infectious disease, including HIV and hepatitis
Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
Patients participating in a study of an experimental drug or medical device within 30 days of study entry.

Sites / Locations

Mayo Clinic Jacksonville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous bone marrow concentrate

Placebo

Arm Description

Subjects with symptomatic mild to moderate bilateral knee osteoarthritis will be enrolled in this study. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the autologous bone marrow aspirate concentrate. The contralateral knee will be injected with only sterile saline for placebo.

Subjects with symptomatic mild to moderate bilateral knee osteoarthritis will be enrolled in this study. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo.

Outcomes

Primary Outcome Measures

Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs)

Occurrence of adverse reactions to concentrated MSCs from bone marrow aspiration injected into knee joints.

Secondary Outcome Measures

Mean Knee Cartilage

Knee cartilage status will be measured prior to injection, at 6 months following injection, and at 12 months following injection. The cartilage will be measured by MRI at baseline and 6 months using MRI and cartilage sequencing techniques, and knee radiographs at 12 months.

Full Information

NCT ID

NCT01931007

First Posted

August 26, 2013

Last Updated

May 3, 2017

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01931007

Brief Title

Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

Acronym

BMAC

Official Title

Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.

Detailed Description

Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and MRI imaging will be performed at 6 months after injection, with repeat radiographs at 12 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bilateral Primary Osteoarthritis of Knee

Keywords

osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous bone marrow concentrate

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects with symptomatic mild to moderate bilateral knee osteoarthritis will be enrolled in this study. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo.

Intervention Type

Drug

Intervention Name(s)

Autologous Bone Marrow Aspirate Concentrate

Intervention Description

Autologous Bone marrow aspirate will be concentrated using Magellan Cell Separator and stem cell kit according to the Standard Operating Procedures is to be injected in the treatment knee. 5ml of treatment cells will be combined with 10 ml of previously separated platelet poor bone marrow plasma and used for injection under ultrasound guidance into one of the subject's painful knees.

Intervention Type

Drug

Intervention Name(s)

Sterile saline

Intervention Description

Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee.

Primary Outcome Measure Information:

Title

Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs)

Description

Occurrence of adverse reactions to concentrated MSCs from bone marrow aspiration injected into knee joints.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Mean Knee Cartilage

Description

Time Frame

baseline, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and Female subjects are both eligible Subjects must be 18 years of age or older Subjects must have bilateral OA and pain in both knees. Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-3. Subjects must have previously tried 6 weeks of one of the following conservative treatments Activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy Patients can provide written informed consent after the nature of the study is fully explained Exclusion Criteria: Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results. Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit. Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry. Patients receiving injections to the treated knee within 2 months prior to study entry. Patients who are pregnant or currently breast-feeding children. Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis. Patients with ongoing infectious disease, including HIV and hepatitis Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes Patients participating in a study of an experimental drug or medical device within 30 days of study entry.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shane Shapiro, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27566242

Citation

Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O'Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455. Epub 2016 Sep 30.

Results Reference

result

PubMed Identifier

27515308

Citation

Camilleri ET, Gustafson MP, Dudakovic A, Riester SM, Garces CG, Paradise CR, Takai H, Karperien M, Cool S, Sampen HJ, Larson AN, Qu W, Smith J, Dietz AB, van Wijnen AJ. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production. Stem Cell Res Ther. 2016 Aug 11;7(1):107. doi: 10.1186/s13287-016-0370-8.

Results Reference

derived

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Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

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