Chronic Musculoskeletal Pain

• Status: Enrolling by invitation
• Trial end date: 2021-08-01
• Target enrollment: 1
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hope Biosciences
• Collaborator: Hope Biosciences Stem Cell Research Foundation

Criteria

Inclusion Criteria:

• 1. Subject is > 18 years of age at the time of signing the informed consent form.

2. Subject has the diagnosis of chronic musculoskeletal pain for a least 1 year or VAS score > 7 a screening visit. 3. Subject has provided informed consent before initiation of any study procedure.

4. Subject and sexual partner if woman of childbearing potential must use a least 1 highly effective form of birth control* throughout the study and for 6 months after the last dose of the investigational product.

Exclusion Criteria:

• 1. Subject has any active infection for which antibiotics were indicated within 4 weeks before screening. 2. Subject has known alcoholic addiction or dependency, uses alcohol daily, or has current substance use or abuse. 3. Subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma, or melanoma. 4. Subject has 1 or more significant concurrent medical conditions per investigator judgment, including the following:

• poorly controlled diabetes.

• chronic kidney disease

• heart failure

• myocardial infarction or unstable angina within 6 months prior to screening.

• uncontrolled hypertension 5. Subject has received any stem cell treatment within 12 months before first dose of investigational product. 6. Subject has laboratory abnormalities during screening, including the following:

• White blood cell count < 3000/mm3

• Platelet count < 125,000mm3

• Absolute neutrophil count < 1500/mm3

• Subject has any other laboratory abnormality, which, in the opinion of the investigator poses a safety risk or will prevent the subject for completing the study.

7. Subject is currently receiving treatment in another investigational drug study.

8. Subject is unlikely to complete the study or adhere to the study procedures.