Autologous Culture Expanded Mesenchymal Stromal Cells for Knee Osteoarthritis

NCT02805855 | Completed Phase 1 FDA Drug

• 1 other identifier: 15-008179
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal stromal cells to treat symptoms of mild to severe knee osteoarthritis.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Number of subjects experiencing adverse events.

  Assess the local and systemic safety of single and multiple injections of human, autologous, culture expanded AMSCs in the treatment of symptomatic knee OA.

  2 years post final injection

Study Arms (4)

S50

EXPERIMENTAL

Subjects in the S50 cohort will receive one injection of 50 million AMSCs.

Drug: Autologous Adipose-Derived Mesenchymal Stromal Cells

S100

EXPERIMENTAL

Subjects in the S100 cohort will receive one injection of 100 million AMSCs.

Drug: Autologous Adipose-Derived Mesenchymal Stromal Cells

M50

EXPERIMENTAL

Subjects in the M50 cohort will receive three injections of 50 million AMSCs at one-month intervals.

Drug: Autologous Adipose-Derived Mesenchymal Stromal Cells

M100

EXPERIMENTAL

Subjects in the M100 cohort will receive three injections of 100 million AMSCs at one-month intervals.

Drug: Autologous Adipose-Derived Mesenchymal Stromal Cells

Interventions

Autologous Adipose-Derived Mesenchymal Stromal Cells DRUG

Human, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices (cGMPs).

Also known as: AMSCs

M100; M50; S100; S50

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ages 40-70 years
• Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit
• Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded. Females in the multiple-dose cohorts (M50 and M100) who become pregnant during the treatment cycle will not receive their remaining injections.
• Chronic (\> 3 months), unilaterally symptomatic, primary femorotibial knee OA
• Radiographic medial and/or lateral femorotibial knee OA at least Kellgren-Lawrence grade 2 accompanied by definite joint space narrowing as agreed upon by two study co-investigators
• Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications or injection therapy (e.g. cortisone, hyaluronic acid/viscosupplement)
• Able to routinely walk without assistance (e.g. cane, walker)
• Clinically stable target knee
• No surgery planned in the target knee for at least 12 months following the last injection
• Completed general physical evaluation with primary care provider within 12 months of enrollment
• Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, repeated knee injections/aspirations, arthroscopic examination and follow-up visits and assessments
• Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure

You may not qualify if:

• Pregnant or nursing, or planning on becoming pregnant during the study period
• Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results
• Significant malalignment on full length, standing radiographs
• Arthroplasty hardware or implantable devices in the index knee (intraosseous screws or other hardware not contacting the articular space are not excluded)
• Surgery on the index knee within 1 year of study enrollment
• Injections of any into the index knee within 3 months prior to study enrollment
• Locking, catching, give-away or another major mechanical symptoms of the target knee
• Symptomatic patellofemoral arthritis or chondromalacia in the index knee
• History of intra-articular infection in the index knee
• History of superficial infection in the index knee within 6 months of study enrollment, or evidence of current superficial infection affecting the index knee
• History of falls requiring medical attention, or gait instability
• Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), bilirubin, creatinine, and CRP
• Body mass index (BMI) \> 40 kg/m2
• Taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix)
• Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the study drug treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin)

Sponsors & Collaborators

• Jacob L. Sellon, M.D.: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jacob Sellon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: October 26, 2016
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)