A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

Recruiting Phase 2 Phase 3 Interventional Study
Osteoarthritis, Knee
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
Nature Cell Co. Ltd. · Industry
Who this trial is looking for

This trial is looking for adults aged 18 and older who have been diagnosed with knee osteoarthritis and are experiencing significant pain and functional limitations. However, they can't have certain serious health issues, like uncontrolled diseases or recent joint therapies, and their weight can't be too high. It’s important that they haven’t had any knee surgeries or treatments in the last six months.

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About This Trial
This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 J…
Trial Locations
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Eligibility Criteria
\<Inclusion Criteria\> 1. Male or female of any race, adult aged 18 years or older 2. Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria) 3. Subject who has ≥ 45 on WOMAC function score at Screening and Baseline 4. Subject who h…
Contacts

Hugh Lee

301-540-2600

hughlee@kcrnresearch.com

CONTACT

Christine Lee

301-540-2600

christinelee@kcrnresearch.com

CONTACT