Individual Patient Expanded Access IND of Autologous HB-adMSCS for the Treatment of Bilateral Knee Pain.

NCT04604288 | Unknown

• 1 other identifier: HBKP01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an Individual Patient Expanded Access IND of autologous adipose derived Mesenchymal Stem Cells with the primary goal of treating 1 individual with bilateral knee pain who has exhausted all treatment options, his condition has not improved, and his quality of life is severely affected by the condition. There are no FDA approved, fully restorative treatments for his condition. The subject will receive 2 autologous HB-adMSCs intravenous infusion of 200 million (2 x 10\^8 cells) total cells, and 4 autologous HB-adMSCs intra-articular injections (1 in each knee joint/ intervention).

Conditions

Knee Pain Chronic; Osteo Arthritis Knee

Keywords

Knee; Knee Pain; Osteoarthritis; Stem Cells; MSCs; Intra-articular

Interventions

HB-adMSC BIOLOGICAL

HB-adMSCs (Hope Biosciences autologous adipose-derived mesenchymal stem cells) is manufactured by Hope Biosciences, L.L.C., a biotechnology company headquartered in Sugar Land, Texas.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of bilateral knee pain.
• Hemodynamically stable.

You may not qualify if:

• Immunosuppression as defined by WBC \< 3, 000 cells/ml at baseline screening.
• Subjects with pro-coagulant disease processes such as Factor V Leiden deficiency, Factor C and S deficiency, anti-thrombin deficiency, prothrombin mutation, and dysfibrinogenemia.
• Subjects with abnormal vital signs, abnormal liver or kidney function, and hematological abnormalities specifically:
• BP systolic: \>160 or \<100 mmHg, DBP: \>100 SBP or \<50mmHg
• Pulse: \<60 or \>105 bpm
• Respiratory Rate: \<9 and \>25 breaths per minute
• Temperature: \>99.9 degrees Fahrenheit
• O2 saturation: \<92%
• Liver enzymes \>2x upper limit of normal (ULN)
• Abnormal bilirubin unless due to benign unconjugated hyperbilirubinemia
• eGFR \<60 mL/min/ 1.73 m2 by CKD-EPI
• HbA1C \>9%
• Hb \<10 mg/dL
• Platelet Count \<100,000
• Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Walter R Lowe, MD

  UT Ortho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)