Who is sponsoring NCT01448434?

NCT01448434 is sponsored by Stempeutics Research Pvt Ltd.

What condition does NCT01448434 study?

NCT01448434 studies Osteoarthritis of Knee Joint.

What drugs are being tested in NCT01448434?

Interventions: Ex- vivo cultured adult allogeneic MSCs, Plasmalyte-A.

What is the status of NCT01448434?

NCT01448434 is currently COMPLETED.

Last reviewed 2016-05-11 · How we verify

A Randomized, Double Blind, Multicentric, Placebo Controlled, Phase -II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients With Osteoarthritis of Knee

NCT01448434 Phase 2 COMPLETED

This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint.

Details

Lead sponsor	Stempeutics Research Pvt Ltd
Phase	Phase 2
Status	COMPLETED
Enrolment	72
Start date	2011-09
Completion	2013-09

Conditions

Osteoarthritis of Knee Joint

Interventions

Ex- vivo cultured adult allogeneic MSCs
Plasmalyte-A

Primary outcomes

Number and percentage of patients with adverse events as a measure of safety and tolerability — 1 year
* Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording. * Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.

Countries

Malaysia