Health TrialsbyHealthPanel

Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis

ConditionsOsteoarthritis, KneeOsteoarthritis, HipOsteoarthritis Shoulder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelltex Therapeutics Corporation

About this trial

This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age above 18 years

Male or female

Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)

Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures

Disqualifiers

Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start

Unwillingness or inability to comply with study procedures

Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.

Clinically active malignant disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Celltex- AdMSCs

    Biological/Vaccine

    Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Treatment groups

300 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Phase 2 Arm 1 - OA KneeExperimental treatment 1 intervention
Group B: Phase 2 Arm 2 OA KneeActive comparator 1 intervention
Group C: Phase 2 Arm 3 - OA HipExperimental treatment 1 intervention
Group D: Phase 2 Arm 4 - OA HipActive comparator 1 intervention
Group E: Phase 2 Arm 5 - OA ShoulderExperimental treatment 1 intervention
Group F: Phase 2 Arm 6 - OA ShoulderActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.

safety

Time frame
12 months
2

Any organ damage or safety concerns determined by SMAC 20 blood test.

Safety

Time frame
12 months

Secondary outcomes

1

Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients

efficacy

Time frame
12 months
2

Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients

efficacy

Time frame
12 months
3

Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients

efficacy

Time frame
12 months
4

Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients

efficacy

Time frame
12 months

Other outcomes

1

Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline

efficacy

Time frame
12 months
2

Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline

efficacy

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celltex Therapeutics Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: