Allogeneic BM-MSCs in Patients With Lumbar Facet Arthropathy (Cellkine)
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|ClinicalTrials.gov Identifier: NCT04410731|
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Facet-Mediated Low Back Pain||Drug: Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Staggered enrollment for subjects 1 to 3, followed by conditioned open enrollment for subjects 4 to 10.|
|Masking:||None (Open Label)|
|Official Title:||CellKine: Phase I Study Evaluating the Safety and Feasibility of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects With Painful Lumbar Facet Joint Arthropathy|
|Actual Study Start Date :||April 28, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: BM-MSC injections for low back pain
Single bilateral intra-articular injections of allogeneic BM-MSCs for lumbar facet joint arthropathy
Drug: Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy
Single bilateral intra-articular injection of manufactured cell cultured expanded allogeneic BM-MSCs for painful lumbar facet joint arthropathy
- Clinical assessment of nature, incidence, and severity of adverse events (AEs) [ Time Frame: 24 months ]Clinical examination face-to-face during follow-up visits
- Self-reported assessment of nature, incidence, and severity of AEs [ Time Frame: 24 months ]Spontaneous subject reports
- Study personnel assessment of nature, incidence, and severity of AEs [ Time Frame: 24 months ]Subject interview by study personnel
- Global Health Scale (GHS) [ Time Frame: 24 months ]Self-reported questionnaire to assess an individual's physical, mental, and social health. Standardized response scores ranges vary from1 to 5 (e.g., 1= None to 5=Very severe) or reversed (5=None to 1=Very severe) to ensure that higher scores for responses always indicate better health.
- Visual Analog Scale (VAS) - back and leg pain [ Time Frame: 24 months ]Subjective self-reported scale (1-10) to measure acute and chronic pain. (0= no pain; 10= worst pain possible).
- Oswestry Disability Index (ODI) [ Time Frame: 24 months ]Self-reported index to quantify disability for low back pain. Scores vary from 0 (no back pain) to 5 (worst back pain) in 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). ODI Index is calculate.
- Patient Health Questionnaire-4 (PHQ-4) [ Time Frame: 24 months ]Self-reported brief questionnaire to screen for anxiety and depression. Four questions scoring 0 (not at all) to 3 (nearly every day).
- Narcotic Use Questionnaire [ Time Frame: 24 months ]Self-reported questionnaire to assess narcotic intake. Four questions to record narcotic drug usage (yes or no), frequency and length.
- Work Status Questionnaire [ Time Frame: 24 months ]Self-reported short questionnaire to assess work status at present. Simple 3 questions to record ability to work and to attend to work.
- PROMIS-CAT [ Time Frame: 24 months ]Patient-Reported Outcomes Measurement Information System to evaluate and monitor physical, mental, and social health. Standardized response scores ranges vary from1 to 5 (e.g., 1= None to 5=Very severe) or reversed (5=None to 1=Very severe) to ensure that higher scores for responses always indicate better health.
- Changes from Baseline evaluated by MRI [ Time Frame: 24 months ]Imaging evaluation by 2 independent radiographic interpretations to determine presence of effusions, bone marrow lesions/peri-articular edema, osteophytes, or any degree of facet synovitis
- Change in number of red blood cells following treatment [ Time Frame: 24 months ]Blood will be drawn in order to monitor for markers of systemic inflammation. The normal range of red blood cells varies slightly between laboratories but is generally between 4.2 - 5.9 million cells/cmm. This can also be referred to as the erythrocyte count and can be expressed in international units as 4.2 - 5.9 x 10^12 cells per liter.
- Change in white blood cells with differential following treatment [ Time Frame: 24 months ]Serological test - Automated white cell differential. A machine generated percentage of the different types of white blood cells, usually split into granulocytes, lymphocytes, monocytes, eosinophils, and basophils.
- Change in number of platelets following treatment [ Time Frame: 24 months ]Serological test: Platelets are not complete cells, but actually fragments of cytoplasm from a cell found in the bone marrow called a megakaryocyte. Platelets play a vital role in blood clotting. Normal range varies slightly between laboratories but is in the range of 150,000 - 400,000/ cmm (150 - 400 x 10^9/liter).
- Change in Serum C-Reactive Protein (CRP) [ Time Frame: 24 months ]Serological test: C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. It is one of a group of proteins called acute phase reactants that go up in response to inflammation. C-reactive protein is measured in milligrams of CRP per liter of blood (mg/L). Normal CRP levels are below 3.0 mg/dL.
- Change in Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 24 months ]Serological test. The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour. It is a common hematology test, and is a non-specific measure of inflammation. The normal range is 0-22 mm/hr for men and 0-29 mm/hr for women.
- Change in Blood Urea Nitrogen (BUN) [ Time Frame: 24 months ]Serological test - basic metabolic panel. A blood urea nitrogen (BUN) test measures the amount of nitrogen in the blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out of the body in the urine. A BUN test is done to see how well the kidneys are working. Results of the blood urea nitrogen test are measured in milligrams per deciliter (mg/dL).
- Change in Creatinine [ Time Frame: 24 months ]Serological test - basic metabolic panel. Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Almost all creatinine is filtered from the blood by the kidneys and released into the urine, so blood levels are usually a good indicator of how well the kidneys are working. Results are reported in mg/dL.
- Change in Sodium [ Time Frame: 24 months ]Serological test - basic metabolic panel. A sodium blood test allows the doctor to see how much sodium is in the subject's blood. It helps maintain normal blood pressure, supports the work of your nerves and muscles, and regulates your body's fluid balance. A normal sodium level is between 135 and 145 milliequivalents per liter (mEq/L) of sodium.
- Change in Potassium [ Time Frame: 24 months ]Serological test - basic metabolic panel. The normal potassium level in the blood is 3.5-5.0 milliEquivalents per liter (mEq/L).
- Change in Chloride [ Time Frame: 24 months ]Serological test - basic metabolic panel. The normal blood reference range of chloride for adults in most labs is 96 to 106 milliequivalents (mEq) per liter.
- Change in Aspartate Aminotransferase (AST) [ Time Frame: 24 months ]Serological test - basic metabolic panel. Inflamed or injured liver cells leak higher than normal amounts of certain chemicals, including liver enzymes, into the bloodstream, which can result in elevated liver enzymes on blood tests. The reference range for aspartate aminotransferase (AST) is as follows: Males: 6-34 IU/L, Females: 8-40 IU/L.
- Change in Glucose [ Time Frame: 24 months ]Serological test - basic metabolic panel. For a subject without diabetes, a fasting blood sugar on awakening should be under 100 mg/dl.
- Change in Carbon Dioxide [ Time Frame: 24 months ]Serological test - basic metabolic panel. The normal range for carbon dioxide is 23 to 29 mEq/L (milliequivalent units per liter of blood).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410731
|Contact: Wenchun Qu, MD, PhDfirstname.lastname@example.org|
|Contact: Erica Engelberg Cook, PhDemail@example.com|
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Erica Engelberg Cook, PhD 904-953-3543 firstname.lastname@example.org|
|Principal Investigator:||Wenchun Qu, MD, PhD||Mayo Clinic|