dMD-001 pilot study

Not Applicable

Completed

• Conditions: Traumatic articular cartilage defects or Osteochondritis dissecans of the knee or elbow

• Registration Number: JPRN-jRCT1080223051
• Lead Sponsor: MOCHIDA PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-21
• Study Completion: 2020-06-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

(1)Patients diagnosed with traumatic articular cartilage defects or osteochondritis dissecans of the knee or elbow
(2)Patients who are KOOS of 70 or less Patients who are Timmerman/Andrews Elbow score of 140 or less
(3)Patients who are cartilage defect area from 1 cm2 to just under 4 cm2
etc

Exclusion Criteria

(1)Patients with 2 or more articular cartilage defects
(2)Patients with Osteoarthritis
(3)Patients who previously had surgical treatment to articular cartilage defects of the target site
(4)Patients with serious Cardiac disorder, Liver disorder, Kidney disorder, Blood disorder, or Endocrine disorders
etc

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>exploratory<br>Efficacy:<br><Knee>KOOS<br><Elbow>Timmerman/Andrews Elbow score<br><Knee and Elbow>Arthroscopic evaluation, MRI evaluation<br>Safety:<br>Adverse events and defect<br>Efficacy:<br><Knee>Change in KOOS<br><Elbow>Change in Timmerman/Andrews Elbow score<br><Knee and Elbow>Evaluation of the cartilage defect site by Arthroscopic, Evaluation of the cartilage defect site by MRI<br>Safety:<br>The incidence of Adverse events and defect

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>exploratory<br>Efficacy:<br>Biopsy<br>Safety:<br>Adverse device effect<br>Efficacy:<br>Evaluation of the cartilage by Biopsy<br>Safety:<br>The incidence of Adverse device effect