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Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

NCT01931007 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-05-05

No results posted yet for this study

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.

Conditions

  • Bilateral Primary Osteoarthritis of Knee

Interventions

DRUG

Autologous Bone Marrow Aspirate Concentrate

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.

DRUG

Sterile saline

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

Sponsors & Collaborators

Principal Investigators

  • Shane Shapiro, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-01-31
Completion
2016-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01931007 on ClinicalTrials.gov