Safety of Mesenchymal Stem Cell Extracellular Vesicles (BM-MSC-EVs) for the Treatment of Burn Wounds

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Mesenchymal stem cells (MSCs) have been used in a variety of clinical applications to repair and regenerate damaged tissue. Previous research has demonstrated the safety and efficacy of delivering bone marrow cells including MSCs to chronic wounds with significant improvement in healing and scarring. Application of mesenchymal stem cell (MSC) therapy to severe burn wounds represents an opportunity for improved outcomes where alternate therapies are limited and often ineffective.

In this protocol, 2nd degree burn wounds will receive direct application of EVs derived from bone marrow MSCs. We have observed success with this type of approach in the past using bone marrow stem cells including MSCs. We have evidence that EVs derived from MSCs are responsible for many of the healing effects produced by MSCs and may be a safer, more reliable alternative to allogeneic cell therapy. This protocol is designed to develop a safe and ideal method of administering bone marrow cell Extracellular Vesicles to wounds.

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

Details

• Lead Sponsor: Aegle Therapeutics
• Collaborator: Congressionally Directed Medical Research Programs

Criteria

Inclusion Criteria:

1. Male or female subjects 18 years of age or older with 2nd Degree Burn Wounds

2. Injury within the prior 48 hours

3. Subjects must understand and give written informed consent.

4. Subjects must agree to have blood draws performed as per protocol

5. Subjects must be accessible for wound treatment and assessment visits

6. Males and females must agree to use an acceptable method of contraception. Exceptions will be females of non-childbearing age and monogamous males who are partners of females of non-childbearing age. Acceptable methods of birth control include; history of sterilization, oral contraceptives, depo-progesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide cream or gel, or an intrauterine device (IUD).

7. Maximum wound size limited to:

• Single wound: ≤ 5% body surface area (BSA)

• Multiple wounds treated in a defined anatomical region with ≤ 20% cumulative TBSA as would correspond to a 70kg subject.

Exclusion Criteria:

1. Solely 1st degree or solely 3rd degree burns

2. Subjects with superficial 2nd degree burn who are expected to heal within 2 weeks post standard therapy

3. Evidence of active infection at the wound site

4. Evidence of significant wound healing prior to treatment

5. Burn wounds requiring skin grafting

6. Wound exclusively located in the area of fingers, toes, face, or perineum

7. Have any requirement for the use of systemic steroids or immunosuppressive

8. Subjects Allergic to human albumin, streptomycin, or penicillin

9. Be a pregnant female or nursing mother

10. Subjects who are known or found to be HIV positive

11. History of alcohol or substance abuse requiring treatment within the past 12 months.

12. Patients with severe medical conditions

1. Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years

2. Life expectancy less than two years

3. Severe cardiopulmonary disease restricting ambulation to the clinical facility

13. WBC <3 or > 20 x109/L, Hgb < 7g/dL, platelets count 50x109/L or less, serum creatinine > 2 times the upper normal limit

14. Those with a known history of coagulopathy

15. Subjects who are potential recipients of tissue or organ transplantation

16. Subjects with circulating Hepatitis B antigen and/or who are seropositive for Hepatitis C antibody

17. History of poor compliance, unreliability