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

Celltex Therapeutics

Status and phase: Not yet enrolling; Phase 2

Conditions: Osteoarthritis, Hip; Osteoarthritis Shoulder; Osteoarthritis, Knee

Treatments: Biological: Celltex- AdMSCs

Study type: Interventional

Funder types: Industry

Identifiers

NCT04448106

CTX0020-002

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.

Exclusion criteria

• 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
• Previous thrombotic disorder
• History of known pulmonary embolism or known secondary anti-phospholipid syndrome
• Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)
• Major trauma or surgery within 14 days of study treatment start
• Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study
• Alcohol, drug, or medication abuse within one year prior to study treatment start
• Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
• Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
• Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
• History of long-term use of immunosuppressive agents
• Organ transplants in the previous 6 months
• Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 6 patient groups

Phase 2 Arm 1 - OA Knee

Experimental group

Description:

50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.

Treatment:

Biological: Celltex- AdMSCs

Phase 2 Arm 2 OA Knee

Active Comparator group

Description:

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Treatment:

Biological: Celltex- AdMSCs

Phase 2 Arm 3 - OA Hip

Experimental group

Description:

50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.

Treatment:

Biological: Celltex- AdMSCs

Phase 2 Arm 4 - OA Hip

Active Comparator group

Description:

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Treatment:

Biological: Celltex- AdMSCs

Phase 2 Arm 5 - OA Shoulder

Experimental group

Description:

50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.

Treatment:

Biological: Celltex- AdMSCs

Phase 2 Arm 6 - OA Shoulder

Active Comparator group

Description:

Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Treatment:

Biological: Celltex- AdMSCs