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

Part of paid clinical trials in El Cajon, California.

Sponsor
Nature Cell Co. Ltd.
Study ID
NCT04368806
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JointStem — DRUG
    Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
  • Placebo Control — OTHER
    Normal Saline with autologous Serum

Study Details

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 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Key Dates

Start date
May 26, 2021
Status verified
Jul 2025
Primary completion
Dec 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JointStem
    Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)
  • Placebo Comparator: Placebo
    Normal Saline with Autologous Serum

Primary Outcome Measure

Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score [ Time Frame: Baseline and Week 48 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
TriWest Research AssociatesEl CajonCalifornia92020
Arthur R. Mabaquiao, M.D.
619-334-4735
David C. Ruiz, Phlebotomist
[email protected]
619-334-4735
BioSolutions Clinical Research CenterLa MesaCalifornia91942
Peter B. Hanson, M.D.
[email protected]
619-637-0770
Tamara Packard, L.V.N.
[email protected]
619-637-0770
Neurovations ResearchNapaCalifornia94558
Eric Grigsby, M.D.
[email protected]
707-252-9666
Louiza Khedim
[email protected]
707-252-9606
Newport TherapeuticsNewport BeachCalifornia92660
Richard Paicius, M.D.
949-644-5800
Zeyn White
[email protected]
949-644-5800
Source HealthcareSanta MonicaCalifornia90403
Timothy T. Davis, M.D.
[email protected]
310-574-2777
Afrida Sara, B.S.
[email protected]
310-574-2777

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TriWest Research Associates· El Cajon, CABioSolutions Clinical Research Center· La Mesa, CANeurovations Research· Napa, CANewport Therapeutics· Newport Beach, CASource Healthcare· Santa Monica, CA

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