Individual Patient Expanded Access IND of HB-adMSCs for Chronic Musculoskeletal Pain.

Chronic Pain Clinical Trial

Official title: Individual Patient Expanded Access IND Using HB-adMSCs for the Treatment of Chronic Musculoskeletal Pain.

Status No longer available

Clinical Trial Summary

This is an Individual Patient Expanded Access IND providing multiple administrations of HBadMSCs for the treatment of Chronic Musculoskeletal Pain. The study duration is approximately 32 weeks, during that time the study subject will complete 1 screening visit, 6 infusion visits, one follow-up visit without infusion and one end of study visit. Next day telephone follow-up visits will occur following each infusion. Efficacy and safety labs as well as quality of life and VAS scores will be obtained.

Clinical Trial Description

Visit 1 - Screening During the screening visit, the principal investigator and/or delegated staff must provide a copy of the IRB-approved informed consent form * to the subject before performing any study procedure.

• IRB must provide a certificate action as proof of approval of the informed consent form.

The study subject should take enough time to read this essential document. If the study subject agrees to participate in the clinical trial, after reading the document, he/she must sign it. By giving his/her signature, study subject allows the principal investigator and/or designated staff to perform the following study procedures:

1. Collection of Medical History.

2. Collection of prior (up to a week before screening) and current medications.

3. Evaluation of Inclusion and Exclusion Criteria.

4. Measurement of Weight in lb. and Height in cm.

5. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.

6. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate.

7. Physical Examination by the principal investigator.

8. Video documentation of the subject walking and expressing the level of pain he/she presents at that visit.

Visits 2, 3, 4, 6 and 7. (Infusions 1, 2, 3, 5 and 6) Throughout these visits, the principal investigator and/or delegated staff will perform the following assessments:

1. Update Medical History Form if necessary.

2. Update Concomitant medications list if applicable.

3. Measurement of Weight in lb.

4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.

5. Completion of study questionaries by the subject.

6. Physical Examination by the principal investigator.

7. Investigational Product Administration:

• Drug Name: HB-adMSCs

• Route: Intravenous

• Dose: 200 million

8. Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first hour (0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).

9. 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events.

10. Adverse Events monitoring.

Visit 5 (Infusions 4)

1. Update Medical History Form if necessary.

2. Update Concomitant medications list if applicable.

3. Measurement of Weight in lb.

4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.

5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate.

6. Completion of study questionaries by the subject.

7. Physical Examination by the principal investigator.

8. Investigational Product Administration:

• Drug Name: HB-adMSCs

• Route: Intravenous

• Dose: 200 million

• Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first hour (0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).

9. 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events.

10. Adverse Events monitoring.

Visit 8 - Phone call Follow Up 1

1. Update Medical History Form if necessary.

2. Update Concomitant medications list if applicable.

3. Adverse Events monitoring.

TREATMENT EXTENSION

After the study subject has completed Visit 7 - Infusion 6, the Principal Investigator will analyze the patient's data to determine if the next series of infusions should be provided. The criteria for making this conclusion are as follows:

• The patient must continue to meet inclusion/exclusion criteria for the study.

• The patient must be experiencing pain as evidenced by the VAS for pain.

• The patient must still be having difficulty in daily physical activities as evidenced by SF36 questionnaire.

• The patient must sign a new informed consent for treatment (s) extension.

Before leaving the infusion center, if the subject is authorized to receive the requested treatment extension, the subject must meet the following discharge criteria:

• Able to ambulate

• Respiration non-labored.

• Alert, oriented.

• SpO2 > 94 % on room air.

• SBP 100 to 139 mmHg & DBP 60 to 89 mmHg

• Heart Rate within normal limits (60 to 100 beats per minute)

Visits 9 and 15 (Infusion 7 and 12)

1. Update Medical History Form if necessary.

2. Update Concomitant medications list if applicable.

3. Measurement of Weight in lb.

4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.

5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate.

6. Completion of study questionaries by the subject.

7. Physical Examination by the principal investigator.

8. Investigational Product Administration:

• Drug Name: HB-adMSCs

• Route: Intravenous

• Dose: 200 million

• Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first hour (0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).

9. 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events.

10. Adverse Events monitoring.

Visits 10, 11, 13, 14, 16 and 17 (Infusions 8, 9, 10, 11, 13 and 14)

1. Update Medical History Form if necessary.

2. Update Concomitant medications list if applicable.

3. Measurement of Weight in lb.

4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.

5. Completion of study questionaries by the subject.

6. Physical Examination by the principal investigator.

7. Investigational Product Administration:

• Drug Name: HB-adMSCs

• Route: Intravenous

• Dose: 200 million

• Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first hour (0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).

8. 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events.

9. Adverse Events monitoring.

Visit 12 - Follow Up Visit.

1. Update Medical History Form if necessary.

2. Update Concomitant medications list if applicable.

3. Measurement of Weight in lb.

4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.

5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate.

6. Completion of study questionaries by the subject.

7. Physical Examination by the principal investigator.

8. Adverse Events monitoring.

Visit 18. (End of Study)

1. Update Medical History Form if necessary.

2. Update Concomitant medications list if applicable.

3. Measurement of Weight in lb.

4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.

5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate.

6. Completion of study questionaries by the subject.

7. Physical Examination by the principal investigator.

8. Adverse Events monitoring. ;

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

• NCT number: NCT04711811
• Study type: Expanded Access
• Source: Hope Biosciences
• Status: No longer available