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

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis Shoulder

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Celltex- AdMSCs

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Autologous Adipose-derived Stem Cells (AdMSCs)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Stanley C Jones

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Phase 2 Arm 1 - OA Knee

Phase 2 Arm 2 OA Knee

Phase 2 Arm 3 - OA Hip

Phase 2 Arm 4 - OA Hip

Phase 2 Arm 5 - OA Shoulder

Phase 2 Arm 6 - OA Shoulder

Arm 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.

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

Outcomes

Primary Outcome Measures

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

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

Safety

Secondary Outcome Measures

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

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

efficacy

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

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

efficacy

Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients

efficacy

Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients

efficacy

changes in joint images (X-ray or MRI) from the baseline

efficacy

Full Information

NCT ID

NCT04448106

First Posted

June 22, 2020

Last Updated

April 13, 2023

Sponsor

Celltex Therapeutics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04448106

Brief Title

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

Acronym

AdMSCs

Official Title

Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 25, 2023 (Anticipated)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celltex Therapeutics Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis Shoulder

Keywords

Autologous Adipose-derived Stem Cells (AdMSCs)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.

Masking

ParticipantOutcomes Assessor

Masking Description

Patients and evaluators

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase 2 Arm 1 - OA Knee

Arm Type

Experimental

Arm Description

Arm Title

Phase 2 Arm 2 OA Knee

Arm Type

Active Comparator

Arm 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

Arm Title

Phase 2 Arm 3 - OA Hip

Arm Type

Experimental

Arm Description

Arm Title

Phase 2 Arm 4 - OA Hip

Arm Type

Active Comparator

Arm 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

Arm Title

Phase 2 Arm 5 - OA Shoulder

Arm Type

Experimental

Arm Description

Arm Title

Phase 2 Arm 6 - OA Shoulder

Arm Type

Active Comparator

Arm 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

Intervention Type

Biological

Intervention Name(s)

Celltex- AdMSCs

Other Intervention Name(s)

AdMSCs

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

safety

Time Frame

12 months

Title

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

Description

Safety

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

efficacy

Time Frame

12 months

Title

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

Description

efficacy

Time Frame

12 months

Title

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

Description

efficacy

Time Frame

12 months

Title

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

Description

efficacy

Time Frame

12 months

Title

Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients

Description

efficacy

Time Frame

12 month

Title

Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients

Description

efficacy

Time Frame

12 months

Title

changes in joint images (X-ray or MRI) from the baseline

Description

efficacy

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

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

Description

efficacy

Time Frame

12 months

Title

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

Description

efficacy

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jane Young

Phone

7135901000

jyoung@celltexbank.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Derek W Guillory, MD.

Organizational Affiliation

Root Causes Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanley C Jones

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sally McGahee, BS

Phone

713-590-1000

Ext

147

smcgahee@celltexbank.com

12. IPD Sharing Statement

Learn more about this trial

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

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