Trial Outcomes & Findings for Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus (NCT NCT01786707)
NCT ID: NCT01786707
Last Updated: 2017-07-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
2 participants
Primary outcome timeframe
1 year
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Autologous Stem Cell and HOT
Autologous stem cells (SC) and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.
|
Control Group
Patients in a control group will continue with standard medical treatment (SMT)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Autologous Stem Cell and HOT
Autologous stem cells (SC) and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.
|
Control Group
Patients in a control group will continue with standard medical treatment (SMT)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Autologous SC and HOT
n=1 Participants
Autologous stem cells and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.
|
Control Group
n=1 Participants
Patients in a control group will continue with standard medical treatment (SMT)
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Autologous SC and HOT
n=1 Participants
Autologous stem cells and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.
|
Control Group
n=1 Participants
Patients in a control group will continue with standard medical treatment (SMT)
|
|---|---|---|
|
Number of Participants With a Reduction of HbA1c of >0.5%
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at 1 yearOutcome measures
| Measure |
Autologous SC and HOT
n=1 Participants
Autologous stem cells and hyperbaric oxygen therapy
Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.
|
Control Group
n=1 Participants
Patients in a control group will continue with standard medical treatment (SMT)
|
|---|---|---|
|
The Number of Subjects With a Reduction of >1% in HbA1c
|
0 Participants
|
0 Participants
|
Adverse Events
Autologous SC and HOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rodolfo Alejandro
University of Miami School of Medicine
Phone: 3052435324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place