Status:
ACTIVE_NOT_RECRUITING
Impact of Mesenchymal Stem Cells in Knee Osteoarthritis
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Case Western Reserve University
Conditions:
Musculoskeletal Pain
Knee Osteoarthritis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MS...
Eligibility Criteria
Inclusion
- Knee Osteoarthritis Subjects
- Male or female 18-60 years of age
- Confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings
- Unilateral chronic knee pain \>4 months
- Imaging findings consistent with mild-moderate generalized cartilage degeneration (MRI chondropathy or radiographic changes)
- Failed non-invasive modalities of treatment
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \<1% per year during the treatment period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\<12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Period abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
- Focal Chondral Defect Subjects
- Male or female 18-60 year of age
- Knee pain and/or effusion
- Inability to continue or difficulty in participation in recreational or professional sport
- MRI with Outerbridge Grade 4 focal chondral defect
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \<1% per year during the treatment period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\<12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Period abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Exclusion
- Radiographic findings consistent with Kellgren-Lawrence Stage 4 disease
- Focal chondral defect
- Major axial deviation (\>5 degrees varus or valgus)
- Concomitant ligamentous or meniscal injury
- BMI \> 40 as defined by NIH Clinical Guidelines Body Mass Index
- Women who are pregnant, breastfeeding or unwilling to practice birth control during participation in the study
- Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days), or have received prior intra-articular injection of any form
- • Or plans to participate in any other allogeneic stem cell therapy trial during the 2-year follow-up period
- Symptomatic active cardiac or respiratory disease that requires scheduled use of medication
- Neurologic disorder including, but not limited to epilepsy, Parkinson's disease, dementia, cerebrovascular disease, tumor of the nervous system, and amyotrophic lateral sclerosis.
- Psychiatric disorder including, but not limited to schizophrenia, bipolar disorder, personality disorder, depression, anxiety, or any other mental illness that would prevent the completion of the study
- Current immunosuppression from medication or disease
- History of systemic malignancy
- History of infection with hepatitis B, C, or HIV
- History of inflammatory arthropathy
- History of prior local knee infection
- Major surgeries, other than diagnostic surgery within 4 weeks
- Contraindication to MRI:
- Indwelling medical devices such as pacemakers, aneurysm clips, etc.
- Indwelling metal from any other cause (trauma, etc.). To be excluded with history and/or radiographs, as necessary
- Screening hematology with white blood cell count \< 4.5 x 109 cells/L, hematocrit \<30%, and platelets \<150 x 109 platelets/L
- Have a known history of hypersensitivity or anaphylactic reaction to Dimethyl sulfoxide (DMSO)
- Have been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program
- Subject unlikely to complete the study as determined by the Investigator
- Subjects must have normal marrow function, and be clinically stable with no significant changes in health status within 2 weeks prior to cell collection that the PI/Sub-Investigator deems relevant to exclude from participation. (See below for details of the cell collection procedure)
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03477942
Start Date
October 1 2018
End Date
July 1 2026
Last Update
September 30 2025
Active Locations (1)
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1
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States, 44106