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

Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

Hope Biosciences Research Foundation

Conditions:

Chronic Pain

Eligibility:

All Genders

18+ years

Brief 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...

Detailed 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 ...

Eligibility Criteria

Inclusion

IND # 27057
Subject is \> 18 years of age at the time of signing the informed consent form.
Subject has the diagnosis of chronic musculoskeletal pain for a least 1 year or VAS score \> 7 a screening visit.
Subject has provided informed consent before initiation of any study procedure.
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

Subject has any active infection for which antibiotics were indicated within 4 weeks before screening.
Subject has known alcoholic addiction or dependency, uses alcohol daily, or has current substance use or abuse.
Subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
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
Subject has received any stem cell treatment within 12 months before first dose of investigational product.
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.
Subject is currently receiving treatment in another investigational drug study.
Subject is unlikely to complete the study or adhere to the study procedures.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04711811

Last Update

September 29 2025

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