Chronic Kidney DiseasesPhase 2NCT05018416
Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
A Phase 2 study testing Renal Autologous Cell Therapy (REACT) in people with Chronic Kidney Diseases and Type 1 Diabetes Mellitus, run by Prokidney at 5 sites in United States.
Trial summary
The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- Renal Autologous Cell Therapy (REACT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Jul 2021to 20 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
- Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care.
- The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
- The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
- The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.
Who cannot join
- The subject has a history of renal transplantation.
- The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.
- Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.
- The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for Chronic Kidney Disease-related anemia prior to randomization.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kidney Associates of Colorado, P.C. - Frenova
Denver, Colorado, 80210-5073
Paragon Health, PC d/b/a Nephrology Center, PC - Frenova
Kalamazoo, Michigan, 49007-3889
Boise Kidney and Hypertension Institute - Frenova
Nampa, Idaho, 83687
Nephrology Associates
Newark, Delaware, 19713
Nephrology and Hypertension Associates Ltd - Frenova
Tupelo, Mississippi, 38801-6560
About this study
Official title: A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease (CKD).
Read the detailed description
The objective of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT)/ rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD):
- Cohort 1: Two scheduled REACT/ rilparencel injections given 3 months (+60 days) with at least 18- month follow-up
- Cohort 2: One scheduled REACT/ rilparencel injection with a possible second REACT/ rilparencel injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT/ rilparencel injection).
Both cohorts will be followed for 18 months after the final REACT/ rilparencel injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.
- Being tested
- Renal Autologous Cell Therapy (REACT)
- Keywords
- Kidney Biopsy, Renal Autologous Cell Therapy (REACT), rilparencel
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Autologous Cell Therapy (REACT)Biological
Also called rilparencel
Autologous selected renal cells (SRC)
| Study group | Role | What they receive |
|---|---|---|
| 2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections | Experimental | Cohort 1 subjects will receive 2 REACT/ rilparencel injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days). Receives: Biological: Renal Autologous Cell Therapy (REACT) |
| 1 Renal Autologous Cell Therapy (REACT)/ rilparencel Injection | Experimental | Cohort 2 subjects will receive 1 REACT / rilparencel injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT/ rilparencel injection into the contralateral kidney. Receives: Biological: Renal Autologous Cell Therapy (REACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation
Measured: Screening thru month 28
Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
Measured: Screening thru 18 months after the last injection of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start27 Jul 2021
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prokidney
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Taylor, Study director, Prokidney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018416
- Sponsor's protocol ID
- REGEN-007
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2;21(5):744-53. doi: 10.2215/CJN.0000000969. Online ahead of print.
PubMed 41481370
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
- ClinicalTrials.gov ID
- NCT05018416
- Acronym / sponsor ID
- REGEN-007
- Keywords
- Kidney Biopsy, Renal Autologous Cell Therapy (REACT), rilparencel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- ProkidneyIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease (CKD).
Detailed description
The objective of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT)/ rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD):
- Cohort 1: Two scheduled REACT/ rilparencel injections given 3 months (+60 days) with at least 18- month follow-up
- Cohort 2: One scheduled REACT/ rilparencel injection with a possible second REACT/ rilparencel injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT/ rilparencel injection).
Both cohorts will be followed for 18 months after the final REACT/ rilparencel injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections | Experimental | Biological: Renal Autologous Cell Therapy (REACT)Cohort 1 subjects will receive 2 REACT/ rilparencel injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days). |
| 1 Renal Autologous Cell Therapy (REACT)/ rilparencel Injection | Experimental | Biological: Renal Autologous Cell Therapy (REACT)Cohort 2 subjects will receive 1 REACT / rilparencel injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT/ rilparencel injection into the contralateral kidney. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
- Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care.
- The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
- The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
- The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.
Key exclusion criteria (4 listed)
- The subject has a history of renal transplantation.
- The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.
- Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.
- The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for Chronic Kidney Disease-related anemia prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Autologous Cell Therapy (REACT)Also: rilparencelAutologous selected renal cells (SRC) | Biological | 1 Renal Autologous Cell Therapy (REACT)/ rilparencel Injection, 2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections |
Primary outcome
Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation
Time frame: Screening thru month 28
Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
Time frame: Screening thru 18 months after the last injection of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 41481370Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2;21(5):744-53. doi: 10.2215/CJN.0000000969. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Taylor study director
Prokidney
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal Autologous Cell Therapy (REACT) in people with Chronic Kidney Diseases and Type 1 Diabetes Mellitus, run by Prokidney at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation (time frame: Screening thru month 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.