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Mesenchymal Stem Cell Therapy for Knee Osteoarthritis

NCT05288725 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-21

No results posted yet for this study

Summary

The study is a multicentered, randomized, double-blinded, placebo-controlled study conducted on the unilateral knee of 120 patients. The study compares the effectiveness of an injection of a mesenchymal stem cell preparation from autologous bone marrow aspirate (BMA) to a corticosteroid control for knee osteoarthritis. WOMAC, VAS pain scores, and MRI will be used for assessment. The study will be conducted at 3 sites in the United States.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Bone Marrow Derived MSCs

Autologous bone marrow aspirate (BMA) is an orthobiologic injection used in knee osteoarthritis therapy. Bone marrow aspirate is harvested from the posterior superior iliac crest (PSIS) of the spine using the Marrow Cellutions kit. BMA will be injected into the knee using ultrasound guidance.

DRUG

Corticosteroid

The corticosteroid is prepared in a 10 ml syringe by combining 1-2 mL Kenalog \[40 mg/dL\], 6-8 mL sterile normal saline, 3-4 mL Ropivicaine 1%.

DEVICE

Bone Marrow Aspirate

The Marrow Cellutions kit is an FDA approved device for harvesting bone marrow aspirate.

Sponsors & Collaborators

  • Next Generation Regenerative Medicine LLC

    lead NETWORK

Principal Investigators

  • Michael A Scarpone, D.O. · Next Generation Regenerative Medicine LLC

  • James G Unnerstall · Next Generation Regenerative Medicine LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-06-30
Completion
2024-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT05288725 on ClinicalTrials.gov