Trial Outcomes & Findings for Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS) (NCT NCT03268603)
NCT ID: NCT03268603
Last Updated: 2025-04-02
Results Overview
The number of adverse events experienced by subjects
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
12-months
Results posted on
2025-04-02
Participant Flow
75 participants signed the informed consent form, however nine participants screened failed prior to being randomized.
Participant milestones
| Measure |
Mesenchymal Stromal Cells
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Mesenchymal Stromal Cells
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawn due to disease progression
|
2
|
Baseline Characteristics
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
Baseline characteristics by cohort
| Measure |
Mesenchymal Stromal Cells
n=57 Participants
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-monthsThe number of adverse events experienced by subjects
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=57 Participants
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Adverse Events
|
668 Number of Adverse Events
|
PRIMARY outcome
Timeframe: 12-monthsThe number of unexpected severe adverse events experienced by subjects
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=57 Participants
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Unexpected Severe Adverse Events
|
41 Number of unexpected severe adverse eve
|
SECONDARY outcome
Timeframe: baseline, approximately 1 yearThe ALSFRS-R includes 12 questions. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best. The change in slope is the rate at which a patient's functional ability declines over time, as measured by the change in the ALFSFRS score over 1 year. A steeper slope signifies a faster decline in function. A negative change in slope indicates a decline in function and positive change in slope indicates an improvement in function.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=57 Participants
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Change in Slope of ALS Functional Rating Scale - Revised (ALSFRS-R)
|
-0.11 Score on a scale/year
Interval -1.19 to 0.93
|
Adverse Events
Mesenchymal Stromal Cells
Serious events: 26 serious events
Other events: 56 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Mesenchymal Stromal Cells
n=57 participants at risk
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Infections and infestations
Appendicitis
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Disease Progression
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Dysphagia
|
19.3%
11/57 • Number of events 11 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Feeding Tube Placement
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders-Other
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Vascular disorders
Hematoma
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Infections and Infestations-Other
|
7.0%
4/57 • Number of events 5 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.8%
1/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
3/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Nervous system disorders
Stroke
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Vascular disorders
Superficial Thrombophlebitis
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Upper Respiratory Infection
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Investigations
Weight Loss
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
Other adverse events
| Measure |
Mesenchymal Stromal Cells
n=57 participants at risk
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
82.5%
47/57 • Number of events 101 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Nervous system disorders
Headache
|
57.9%
33/57 • Number of events 63 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Abrasion on the left side of head
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Immune system disorders
Allergic Reaction
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Anal Fissure
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Nervous system disorders
Arachnoiditis
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Ankle Pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Left Buttock Pain and Leg Pain Post Procedure
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Black Hairy Tongue
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders-Other
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
19/57 • Number of events 41 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
40.4%
23/57 • Number of events 33 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Chills
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Psychiatric disorders
Confusion
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Constipation
|
17.5%
10/57 • Number of events 10 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
6/57 • Number of events 6 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Investigations
Creatinine Increased
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
3/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Psychiatric disorders
Depression
|
5.3%
3/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
8.8%
5/57 • Number of events 6 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Nervous system disorders
Dysarthria
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Dysphagia
|
14.0%
8/57 • Number of events 8 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Face Edema
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Limb Edema
|
7.0%
4/57 • Number of events 5 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Eye disorders
Eye Disorder-Other
|
5.3%
3/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Eye Infection
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Facial Pain
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
77.2%
44/57 • Number of events 115 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Fatigue
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Feeding Tube Placement
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Fever
|
1.8%
1/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Food Poisoning
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Forehead Abrasion
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fracture
|
7.0%
4/57 • Number of events 4 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Gait Disturbance
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.3%
3/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
General Disorders and Administration Site Conditions-Other
|
5.3%
3/57 • Number of events 7 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Hamstring Stiffness
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Hangover Feeling
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Head Cold
|
7.0%
4/57 • Number of events 5 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Head Laceration
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Vascular disorders
Hematoma
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Vascular disorders
Hypotension
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Infections and Infestations-Other
|
15.8%
9/57 • Number of events 9 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Influenza B
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Ingrown Toe Nails
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Injection Site Soreness
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications-Other
|
7.0%
4/57 • Number of events 6 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Left Shoulder Abrasion
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
8.8%
5/57 • Number of events 5 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Low Back and Left Leg Pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain Tailbone
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain and Upper Thigh Pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Soreness
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Stiffness
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Lung Infection
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder-Other
|
5.3%
3/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
15.8%
9/57 • Number of events 9 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
4/57 • Number of events 4 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
10.5%
6/57 • Number of events 6 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)-Other
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Norovirus Vomiting
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Oral Thrush
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Pain
|
17.5%
10/57 • Number of events 21 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
50.9%
29/57 • Number of events 65 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
3.5%
2/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Cardiac disorders
Palpitations
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Nervous system disorders
Paresthesia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Post Injection Low Back and Left Leg Pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Psychiatric disorders
Restlessness
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Scabs on Face from Walking into a Cable
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Sinus Infection
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Cardiac disorders
Sinus Tachycardia
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Sinusitis
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
5.3%
3/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Sore, Achy Hamstrings and Calves-Bilateral
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.8%
1/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Surgical and medical procedures
Surgical and Medical Procedures-Other
|
3.5%
2/57 • Number of events 3 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
General disorders
Swollen Feet
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Tailbone Pain
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Upper Respiratory Infection
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Renal and urinary disorders
Urinary Frequency
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Renal and urinary disorders
Urinary Retention
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Infections and infestations
Urinary Tract Infection
|
8.8%
5/57 • Number of events 10 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Renal and urinary disorders
Urinary Urgency
|
8.8%
5/57 • Number of events 5 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Ear and labyrinth disorders
Vertigo
|
7.0%
4/57 • Number of events 6 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
4/57 • Number of events 4 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place